[Federal Register Volume 88, Number 69 (Tuesday, April 11, 2023)]
[Notices]
[Pages 21684-21685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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-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 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 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.

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, 
[email protected].

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

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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 https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments.
    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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/controlled-correspondence-related-generic-drug-development 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 [email protected]. The draft guidance is available from 
our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-obtain-covered-product-authorization.
    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]
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