Notice2023-07527
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Drug User Fee Program; Controlled Correspondence Related to Generic Drug Development
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 11, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on controlled correspondence related to generic drug development.
Full Text
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<title>Federal Register, Volume 88 Issue 69 (Tuesday, April 11, 2023)</title>
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[Federal Register Volume 88, Number 69 (Tuesday, April 11, 2023)]
[Notices]
[Pages 21684-21685]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-07527]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0941]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Generic Drug User Fee Program; Controlled
Correspondence Related to Generic Drug Development
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on controlled correspondence related to
generic drug development.
DATES: Either electronic or written comments on the collection of
information must be submitted by June 12, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 12, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
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-2018-D-1592 for ``Controlled Correspondence Related to Generic Drug
Development.'' Received comments, those filed in a timely manner (see
ADDRESSES), 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 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.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#68383a293b1c090e0e280e0c094600001b460f071e"><span class="__cf_email__" data-cfemail="17474556446376717157717376397f7f6439707861">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the 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, including
each proposed extension of an existing 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
[[Page 21685]]
of automated collection techniques, when appropriate, and other forms
of information technology.
Generic Drug User Fee Program; Controlled Correspondence
OMB Control Number 0910-0727--REVISION
This information collection supports implementation of FDA's
Generic Drug User Fee program. The Generic Drug User Fee Amendments
(GDUFA) (Pub. L. 112-144, Title III) were enacted to speed the delivery
of safe and effective generic drugs to the public and reduce costs to
industry. GDUFA authorizes FDA to assess user fees to fund critical and
measurable enhancements to the performance of FDA's generic drugs
program, bringing greater predictability and timeliness to the review
of generic drug applications. GDUFA is currently authorized through
September 30, 2027. For more information regarding GDUFA and ongoing
implementation, we invite you to visit our website at <a href="https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments">https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments</a>.
For operational efficiency, we are revising the information
collection to include recommendations found in Agency guidance
currently approved in OMB control no. 0910-0797. As discussed in the
current GDUFA Commitment Letter, found on our website and included in
the information collection, FDA has agreed to specific program
enhancements and performance goals. Accordingly, we issued the guidance
document entitled ``Controlled Correspondence Related to Generic Drug
Development'' (December 2022), to communicate instruction regarding the
process by which generic drug manufacturers and related industry or
their representatives can request information related to generic drug
development. The guidance document also identifies necessary content
elements to facilitate FDA's prompt consideration of the request, as
well as prescribed timeframes. The guidance document is available from
our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/controlled-correspondence-related-generic-drug-development">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/controlled-correspondence-related-generic-drug-development</a> and was issued consistent with our Good Guidance Practice
regulations found in 21 CFR 10.115, which provide for public comment at
any time.
We are also revising the information collection to include Covered
Product Authorization Requests (CPAs), provided for under the Creating
and Restoring Equal Access to Equivalent Samples Act of 2019 (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. To make use of this pathway, an eligible product
developer seeking to develop a product subject to a Risk Evaluation and
Mitigation Strategies with elements to assure safe use must obtain from
the Agency a Covered Product Authorization (see 21 U.S.C. 355-2(b)(2)).
The draft procedural guidance document entitled ``How to Obtain Covered
Product Authorization'' (September 2022) explains that CPAs are
submitted as controlled correspondence to the CDER NextGen
Collaboration Portal and that general questions may be submitted by
email to <a href="/cdn-cgi/l/email-protection#1d5a7873786f747e596f687a6e5d7b797c3375756e337a726b"><span class="__cf_email__" data-cfemail="8bcceee5eef9e2e8cff9feecf8cbedefeaa5e3e3f8a5ece4fd">[email protected]</span></a>. The draft guidance is available from
our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-obtain-covered-product-authorization">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-obtain-covered-product-authorization</a>.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden
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Number of Average
Information collection activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
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GDUFA Controlled Correspondence 390 12.5 4,875 5 24,375
submitted consistent with GFI
Section IV.....................
CPA Requests submitted 10 12.5 125 5 625
consistent with Draft GFI
Section IV.....................
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Total....................... .............. .............. 5,000 .............. 25,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Our burden estimate reflects an increase of 125 responses and 625
hours annually corresponding with the inclusion of CPAs to the
information collection. We have otherwise retained the currently
approved burden estimate associated with controlled correspondence for
generic drug development
Dated: April 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07527 Filed 4-10-23; 8:45 am]
BILLING CODE 4164-01-P
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