Document ID: FDA-2022-N-2335-0001
Agency: fda
Document Type: Notice
Title: Prescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application Review; Statement of Work; Request for Comments
Posted Date: 2022-10-14T04:00Z

[Federal Register Volume 87, Number 198 (Friday, October 14, 2022)]
[Notices]
[Pages 62419-62421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22335]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2335]

Prescription Drug User Fee Act VII; Independent Assessment of 
Communication Through Product Quality Information Requests During 
Application Review; Statement of Work; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the Statement of Work to assess 
communication between FDA and sponsors through product quality 
information requests during application review and to identify best 
practices and areas of improvement. The independent assessment is part 
of FDA performance commitments under the recent reauthorization of the 
Prescription Drug User Fee Act (PDUFA). The independent assessment of 
FDA and sponsors in communicating through product quality information 
requests is described in detail in the document entitled ``PDUFA 
Reauthorization Performance Goals and Procedures Fiscal Years 2023 
Through 2027.'' As part of FDA performance commitments described in 
this document, the assessment will be conducted by an

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independent contractor. FDA is providing for public comment on the 
statement of work before revising as needed and requesting contractor 
proposals.

DATES: Either electronic or written comments on the statement of work 
must be submitted by November 14, 2022.

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 November 14, 2022. 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-2022-N-2335 for ``Prescription Drug User Fee Act VII Commitment to 
Assess Current Practices of the Food and Drug Administration and 
Sponsors in Communicating Through Product Quality Information Requests 
During Application Review.'' 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.'' FDA 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: Emily Ewing, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1148, Silver Spring, MD 20993-0002, 240-
402-0196, [email protected].

SUPPLEMENTARY INFORMATION: PDUFA provides FDA with a source of stable, 
consistent funding that has made it possible for the Agency to focus on 
promoting innovative therapies and help bring to market critical 
products for patients. When PDUFA was originally authorized in 1992, it 
had a 5-year term. The program has been subsequently reauthorized every 
5 years. To prepare for reauthorization of PDUFA for the next 5-year 
period (2023 to 2027), FDA conducted negotiations with the regulated 
industry and held regular consultations with public stakeholders, 
including patient advocates, consumer advocates, and healthcare 
professionals between September 2020 and February 2021.
    Following these discussions, related public meetings, and Agency 
requests for public comment, FDA published the ``PDUFA Reauthorization 
Performance Goals and Procedures Fiscal Years 2023 Through 2027'' 
document, available at https://www.fda.gov/media/151712/download, also 
known as the PDUFA VII ``goals letter,'' to supplement the statute. The 
goals letter includes the performance goals, procedures, and 
commitments that apply to aspects of the human drug review program that 
are important for facilitating timely access to safe, effective, and 
innovative new medicines for patients. Several of these commitments aim 
to continue to enhance communication between FDA and sponsors during 
application review.
    FDA and sponsors interact in a variety of ways throughout 
application review. One such way is via a communication called an 
information request (IR), sent to an applicant as the discipline review 
occurs. FDA uses IRs to request further information or clarification 
that is needed or would be helpful to allow completion of the 
discipline review. IRs may be in the form of letters, emails, or faxes.
    FDA uses product quality IRs to request further information or 
clarification needed for FDA's assessment of identity, strength, 
quality, purity, or potency of drug substances or drug products. 
Ensuring that patients can have confidence in the safety and 
effectiveness of their medications is a longstanding priority for FDA. 
The Center for Drug Evaluation and Research (CDER) and the Center for 
Biologics Evaluation and Research (CBER) have

[[Page 62421]]

worked to address this priority in part by performing Chemistry, 
Manufacturing, and Controls (CMC) reviews for CDER-regulated and CBER-
regulated products. CDER or CBER may issue a product quality, or CMC, 
IR as a result of CMC assessments conducted in support of the 
application.
    IRs from both CDER and CBER are expected to follow Four-Part 
Harmony in which reviewers are expected to communicate: (1) what was 
provided, (2) what is the issue or deficiency, (3) what is needed, and 
(4) why it is needed. This expectation can be found in CDER's Manual of 
Policies and Procedures (MAPP) 5016.8, ``Communication Guidelines for 
Quality-Related Information Requests and Deficiencies.'' As a result of 
FDA's implementation of Four-Part Harmony in CMC-IRs, sponsors should 
understand what information FDA needs to continue their review. The 
PDUFA VII goals letter includes commitments for FDA to update and 
conduct training on existing policies and procedures (MAPPs and 
Standard Operating Policy and Procedure (SOPPs)), to reflect Four-Part 
Harmony. CDER MAPP 5016.8, ``Communication Guidelines for Quality-
Related Information Requests and Deficiencies'' will be revised and 
made public. CBER SOPP 8401.1, ``Issuance of and Review of Responses to 
Information Request Communications to Pending Applications'' will also 
be revised.
    In addition to updating the documents and conducting training, FDA 
is committed to contracting with an independent third party to assess 
current practices of CDER, CBER, and sponsors in communicating through 
product quality IRs during application review and effectiveness of 
Four-Part Harmony. This assessment will identify best practices and 
areas of improvement in communications between FDA review staff and 
sponsors through product quality IRs and is the subject of this task 
order.
    The Statement of Work can be accessed at: https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-assessment-fda-and-sponsor-communications-through-product-quality-information-requests.

    Dated: October 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22335 Filed 10-13-22; 8:45 am]
BILLING CODE 4164-01-P