Prescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application Review; Statement of Work; Request for Comments, 62419-62421 [2022-22335]

Download as PDF jspears on DSK121TN23PROD with NOTICES Federal Register / Vol. 87, No. 198 / Friday, October 14, 2022 / Notices Drug, and Cosmetic Act; or human cells, tissues, or cellular or tissue-based products regulated solely under section 361 of the Public Health Service Act (42 U.S.C. 264) and 21 CFR part 1271. On April 20, 2016, (81 FR 23303), FDA announced the availability of a revised draft guidance entitled ‘‘Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information.’’ This was a revised draft of a draft guidance published in February 2003. We revised the February 2003 draft guidance in 2016 for the following reasons: • To include current pharmaceutical quality concepts. • To provide more flexibility regarding filing procedures for a notification of modifications to an approved CP in less burdensome reporting categories than a prior approval supplement. • To add an appendix to address commonly asked questions. The Center for Veterinary Medicine, which was included in the February 2003 draft guidance, published recommendations for animal drugs in a separate guidance. We received a number of comments on the revised draft guidance, which the Agency considered carefully as it prepared this final guidance. Additional information has been included in the final guidance on proposing an appropriate reporting category for implementation of changes under a CP once approved. Additional examples have been included for notification of modifications to an approved CP in less burdensome reporting categories than a prior approval supplement. Information has been included in the appendix on cross-referencing of a master file, including a Drug Master File, in a CP and submitting a CP to a master file. Also, the recommendations in the guidance for industry ICH Q12 have been carefully considered when revising this guidance to maximize consistency. We also have made clarifications and editorial changes to the final guidance document. This final guidance provides recommendations to original applicants and holders of approved applications for human drugs and certain biological products on implementing CMC postapproval change(s) through the use of a CP. In many cases, submission and approval of a CP will facilitate the subsequent implementation and reporting of CMC changes, which could result in moving a drug or biological product into distribution or facilitating a proactive approach to reinforcing the VerDate Sep<11>2014 17:22 Oct 13, 2022 Jkt 259001 supply of a product sooner than if a CP were not used. The final guidance recommends a framework to promote continuous improvement in the manufacturing of quality drug and biological products by encouraging applicants to employ the following: • Effective use of knowledge and understanding of the product and manufacturing process; • Risk management activities over the life cycle of a product; and • An effective pharmaceutical quality system This final guidance incorporates the modern regulatory concepts stated in the guidance for industry entitled ‘‘PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance,’’ the Pharmaceutical Quality for the 21st Century—A Risk Based Approach, the Critical Path Initiative, and the quality by design principles described in the guidance for industry entitled ‘‘Q8(R2) Pharmaceutical Development.’’ This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA.’’ It does not establish any rights for any person and, with the exception of section V, 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. As noted, insofar as section V of this guidance sets forth that certain modifications to an approved CP must be submitted in a changes being effected supplement or annual report rather than a prior approval supplement, it has binding effect, as indicated by the use of the words must, shall, or required. Such binding effect derives from section 506A of the FD&C Act, as implemented in 21 CFR 314.70 and 601.12. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 314 have been approved under OMB control number 0910–0001. The collections of PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 62419 information in 21 CFR part 601 have been approved under OMB control number 0910–0338. The collections of information in 21 CFR parts 210 and 211 relating to current good manufacturing practices have been approved under OMB control number 0910–0139. The collections of information relating to section 351(k) of the PHS Act have been approved under OMB control number 0910–0718. III. Electronic Access Persons with access to the internet may obtain the guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. Dated: October 7, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–22334 Filed 10–13–22; 8:45 am] BILLING CODE 4164–01–P 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. Notice; establishment of a public docket; request for comments. ACTION: 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 SUMMARY: E:\FR\FM\14OCN1.SGM 14OCN1 62420 Federal Register / Vol. 87, No. 198 / Friday, October 14, 2022 / Notices independent contractor. FDA is providing for public comment on the statement of work before revising as needed and requesting contractor proposals. Either electronic or written comments on the statement of work must be submitted by November 14, 2022. DATES: 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. ADDRESSES: 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’’). jspears on DSK121TN23PROD with NOTICES 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 VerDate Sep<11>2014 17:22 Oct 13, 2022 Jkt 259001 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-201509-18/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. PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 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, Emily.Ewing@fda.hhs.gov. 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 E:\FR\FM\14OCN1.SGM 14OCN1 Federal Register / Vol. 87, No. 198 / Friday, October 14, 2022 / Notices worked to address this priority in part by performing Chemistry, Manufacturing, and Controls (CMC) reviews for CDER-regulated and CBERregulated 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-fdaand-sponsor-communications-throughproduct-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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–N–0008] Request for Nominations for Individuals and Consumer Organizations for Advisory Committees AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of individuals on its advisory committee regardless of their gender identification, religious affiliation, racial and ethnic identification, or disability status and, therefore, encourages nominations of appropriately qualified candidates from all groups. DATES: Any consumer organization interested in participating in the selection of an appropriate voting or SUMMARY: nonvoting member to represent consumer interests on an FDA advisory committee or panel may send a letter or email stating that interest to FDA (see ADDRESSES) by November 28, 2022, for vacancies listed in this notice. Concurrently, nomination materials for prospective candidates should be sent to FDA (see ADDRESSES) by November 28, 2022. Nominations will be accepted for current vacancies and for those that will or may occur through December 31, 2023. All statements of interest from consumer organizations interested in participating in the selection process should be submitted electronically to ACOMSSubmissions@fda.hhs.gov or by mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993–0002. Consumer representative nominations should be submitted electronically by logging into the FDA Advisory Committee Membership Nomination Portal: https://www.accessdata.fda.gov/ scripts/FACTRSPortal/FACTRS/ index.cfm, or by mail to Advisory Committee Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993– 0002. Additional information about becoming a member of an FDA advisory committee can also be obtained by visiting FDA’s website at https:// www.fda.gov/AdvisoryCommittees/ default.htm. ADDRESSES: FOR FURTHER INFORMATION CONTACT: For questions relating to participation in the selection process: Kimberly Hamilton, Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993–0002, 301– 796–8220, kimberly.hamilton@ fda.hhs.gov. For questions relating to specific advisory committees or panels, contact the appropriate contact person listed in table 1. TABLE 1—ADVISORY COMMITTEE CONTACTS jspears on DSK121TN23PROD with NOTICES Contact person Committee/panel Rakesh Raghuwanshi, Office of the Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3309, Silver Spring, MD 20993–0002, 301–796–4769, Rakesh.Raghuwanshi@ fda.hhs.gov. Prabhakara Atreya, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1226, Silver Spring, MD 20993–0002, 240–402–8006, Prabhakara.Altreya@fda.hhs.gov. VerDate Sep<11>2014 17:22 Oct 13, 2022 Jkt 259001 PO 00000 Frm 00063 Fmt 4703 FDA Science Board Advisory Committee. Allergenic Products Advisory Committee. Sfmt 4703 62421 E:\FR\FM\14OCN1.SGM 14OCN1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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

[[Page 62420]]

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

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