Controlled Correspondence Related to Generic Drug Development; Draft Guidance for Industry; Availability, 78691-78693 [2022-27827]

Download as PDF Federal Register / Vol. 87, No. 245 / Thursday, December 22, 2022 / Notices FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Takyiah Stevenson (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: December 16, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–27834 Filed 12–21–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–0417] Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health. Nominations will be accepted for current and upcoming vacancies effective February 1, 2023, with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups. DATES: Nominations received on or before February 21, 2023, will be given first consideration for membership on the National Mammography Quality Assurance Advisory Committee. Nominations received after February 21, 2023, will be considered for nomination lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 18:01 Dec 21, 2022 Jkt 259001 to the committee as later vacancies occur. ADDRESSES: All nominations for membership should be submitted electronically by logging into the FDA Advisory Nomination Portal at https:// www.accessdata.fda.gov/scripts/ FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993–0002. Information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA’s website at https:// www.fda.gov/AdvisoryCommittees/ default.htm. FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for membership: James P. Swink, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5211, Silver Spring, MD 20993, 301–796– 6313, James.Swink@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting members to fill upcoming vacancies on the National Mammography Quality Assurance Advisory Committee. I. General Description of the Committee Duties The National Mammography Quality Assurance Advisory Committee advises the Commissioner of Food and Drugs (the Commissioner) or designee on: (1) developing appropriate quality standards and regulations for mammography facilities; (2) developing appropriate standards and regulations for bodies accrediting mammography facilities under this program; (3) developing regulations with respect to sanctions; (4) developing procedures for monitoring compliance with standards; (5) establishing a mechanism to investigate consumer complaints; (6) reporting new developments concerning breast imaging that should be considered in the oversight of mammography facilities; (7) determining whether there exists a shortage of mammography facilities in rural and health professional shortage areas and determining the effects of personnel on access to the services of such facilities in such areas; (8) determining whether there will exist a sufficient number of medical physicists after October 1, 1999; and (9) determining the costs and benefits of compliance with these requirements. II. Criteria for Voting Members The committee consists of a core of 15 members, including the Chair. Members PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 78691 and the Chair are selected by the Commissioner or designee from among physicians, practitioners, and other health professionals, whose clinical practice, research specialization, or professional expertise includes a significant focus on mammography. Almost all non-Federal members of this committee serve as Special Government Employees. Members will be invited to serve for terms of up to 4 years. III. Nomination Procedures Any interested person may nominate one or more qualified persons for membership on the advisory committee. Self-nominations are also accepted. Nominations must include a current, complete re´sume´ or curriculum vitae for each nominee, including current business address, telephone number, and email address if available, and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Nomination Portal (see ADDRESSES). Nominations must specify the advisory committee for which the nominee is recommended. Nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will ask potential candidates to provide detailed information concerning such matters related to financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflict of interest. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: December 16, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–27883 Filed 12–21–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–1167] Controlled Correspondence Related to Generic Drug Development; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Controlled Correspondence Related to Generic Drug Development.’’ This guidance provides information SUMMARY: E:\FR\FM\22DEN1.SGM 22DEN1 78692 Federal Register / Vol. 87, No. 245 / Thursday, December 22, 2022 / Notices regarding the process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development and the Agency’s process for providing communications related to such correspondence. This guidance also describes the process by which generic drug manufacturers and related industry can submit requests to clarify ambiguities in FDA’s controlled correspondence response and the Agency’s process for responding to those requests. This draft guidance revises the guidance for industry entitled ‘‘Controlled Correspondence Related to Generic Drug Development’’ issued in December 2020. DATES: Submit either electronic or written comments on the draft guidance by February 21, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. 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’’). lotter on DSK11XQN23PROD with NOTICES1 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. VerDate Sep<11>2014 18:01 Dec 21, 2022 Jkt 259001 • 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– 2014–D–1167 for ‘‘Controlled Correspondence Related to Generic Drug Development.’’ 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 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 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 electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Lisa Bercu, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1672, Silver Spring, MD 20993–0002, 240–402–6902. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Controlled Correspondence Related to Generic Drug Development.’’ This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit to FDA controlled correspondence requesting information related to generic drug development and the Agency’s process for providing communications related to such correspondence. This guidance also describes the process by which generic drug manufacturers and related industry can submit requests to clarify ambiguities in FDA’s controlled correspondence response and the Agency’s process for responding to those requests. In accordance with the Generic Drug User Fee Amendments (GDUFA) Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023–2027 (GDUFA III commitment letter), FDA agreed to certain review goals and procedures for the review of controlled correspondence received on or after October 1, 2022. The GDUFA III commitment letter defines level 1 controlled correspondence and level 2 controlled correspondence, and the draft guidance provides additional details and recommendations concerning what inquiries FDA considers controlled correspondence for the purposes of meeting the Agency’s performance goals under the GDUFA III commitment letter. In addition, this guidance provides details and recommendations concerning what information requestors should include in a controlled correspondence to facilitate FDA’s consideration of and response to a controlled correspondence and what information FDA will provide in its communications to requestors that have E:\FR\FM\22DEN1.SGM 22DEN1 Federal Register / Vol. 87, No. 245 / Thursday, December 22, 2022 / Notices submitted controlled correspondence. As described in the GDUFA III commitment letter, FDA has also agreed to review and respond to requests to clarify ambiguities in the controlled correspondence response, and the guidance provides information on how requestors can submit these requests and the Agency’s process for responding to them. This draft guidance revises the guidance for industry entitled ‘‘Controlled Correspondence Related to Generic Drug Development’’ issued in December 2020. When finalized, this updated guidance will replace the December 2020 guidance. Changes from the 2020 version include updating the guidance to reflect enhancements in the GDUFA III commitment letter (e.g., including information on controlled correspondence that can be submitted during abbreviated new drug application assessment and after issuance of a complete response letter or a tentative approval or approval); providing additional recommendations on requests for information related to inactive ingredients; and other updates that are intended to clarify FDA’s recommendations to industry. 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 ‘‘Controlled Correspondence Related to Generic Drug Development.’’ 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 lotter on DSK11XQN23PROD with NOTICES1 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 parts 312 and 314 have been approved under OMB control numbers 0910–0014 and 0910– 0797, respectively. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fda- VerDate Sep<11>2014 18:01 Dec 21, 2022 Jkt 259001 78693 guidance-documents, or https:// www.regulations.gov. Q-Submissions Program for Medical Devices Dated: December 16, 2022. Lauren K. Roth, Associate Commissioner for Policy. OMB Control Number 0910–0756— Revision The guidance entitled ‘‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’’ (https://www.fda.gov/media/ 114034/download) provides an overview of the mechanisms available to submitters through which they can request feedback from, or a meeting with, FDA regarding certain potential or planned medical device submissions reviewed by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). The guidance provides recommendations regarding certain types of Q-Submissions, such as Pre-Submissions, Submission Issue Requests, Study Risk Determinations, Informational Meetings, and other QSubmission types and other uses of the Q-Submission Program. Respondents are medical device manufacturers subject to FDA’s laws and regulations. FDA’s annual estimate of 3,700 submissions is based on recent trends. FDA’s administrative and technical staffs, who are familiar with Q-Submissions, estimate that an average of 137 hours is needed to prepare a QSubmission. [FR Doc. 2022–27827 Filed 12–21–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–0530] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Q-Submission Program for Medical Devices AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. SUMMARY: Submit written comments (including recommendations) on the collection of information by January 23, 2023. DATES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0756. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 Early Payor Feedback Program Prior to submitting a Pre-Submission, medical device sponsors may request that one or more payor organizations join a Pre-Submission meeting. Payors include public payors such as Centers for Medicare & Medicaid Services, private health plans, health technology assessment groups, and others who provide input into coverage, procurement, and reimbursement decisions. To facilitate such opportunities to obtain payor input, FDA provides information about our Early Payor Feedback Program (EPFP) and a list of current payor participants on our website (https://www.fda.gov/ about-fda/cdrh-innovation/payorcommunication-task-force). For payors to decide which devices to provide feedback on, we have developed a voluntary form for manufacturers to provide basic information regarding their device. This form is shared with the payors from whom the manufacturer is requesting feedback. We expect preparation and submission of the form to take no more than 2 hours. eSTAR for Q-Submissions Under section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k–1(b)), amended by E:\FR\FM\22DEN1.SGM 22DEN1

Agencies

[Federal Register Volume 87, Number 245 (Thursday, December 22, 2022)]
[Notices]
[Pages 78691-78693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27827]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1167]


Controlled Correspondence Related to Generic Drug Development; 
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Controlled 
Correspondence Related to Generic Drug Development.'' This guidance 
provides information

[[Page 78692]]

regarding the process by which generic drug manufacturers and related 
industry can submit controlled correspondence to FDA requesting 
information related to generic drug development and the Agency's 
process for providing communications related to such correspondence. 
This guidance also describes the process by which generic drug 
manufacturers and related industry can submit requests to clarify 
ambiguities in FDA's controlled correspondence response and the 
Agency's process for responding to those requests. This draft guidance 
revises the guidance for industry entitled ``Controlled Correspondence 
Related to Generic Drug Development'' issued in December 2020.

DATES: Submit either electronic or written comments on the draft 
guidance by February 21, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

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-2014-D-1167 for ``Controlled Correspondence Related to Generic Drug 
Development.'' 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 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 electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Lisa Bercu, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 75, Rm. 1672, Silver Spring, MD 20993-0002, 240-402-6902.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Controlled Correspondence Related to Generic Drug 
Development.'' This guidance provides information regarding the process 
by which generic drug manufacturers and related industry can submit to 
FDA controlled correspondence requesting information related to generic 
drug development and the Agency's process for providing communications 
related to such correspondence. This guidance also describes the 
process by which generic drug manufacturers and related industry can 
submit requests to clarify ambiguities in FDA's controlled 
correspondence response and the Agency's process for responding to 
those requests. In accordance with the Generic Drug User Fee Amendments 
(GDUFA) Reauthorization Performance Goals and Program Enhancements 
Fiscal Years 2023-2027 (GDUFA III commitment letter), FDA agreed to 
certain review goals and procedures for the review of controlled 
correspondence received on or after October 1, 2022.
    The GDUFA III commitment letter defines level 1 controlled 
correspondence and level 2 controlled correspondence, and the draft 
guidance provides additional details and recommendations concerning 
what inquiries FDA considers controlled correspondence for the purposes 
of meeting the Agency's performance goals under the GDUFA III 
commitment letter. In addition, this guidance provides details and 
recommendations concerning what information requestors should include 
in a controlled correspondence to facilitate FDA's consideration of and 
response to a controlled correspondence and what information FDA will 
provide in its communications to requestors that have

[[Page 78693]]

submitted controlled correspondence. As described in the GDUFA III 
commitment letter, FDA has also agreed to review and respond to 
requests to clarify ambiguities in the controlled correspondence 
response, and the guidance provides information on how requestors can 
submit these requests and the Agency's process for responding to them.
    This draft guidance revises the guidance for industry entitled 
``Controlled Correspondence Related to Generic Drug Development'' 
issued in December 2020. When finalized, this updated guidance will 
replace the December 2020 guidance. Changes from the 2020 version 
include updating the guidance to reflect enhancements in the GDUFA III 
commitment letter (e.g., including information on controlled 
correspondence that can be submitted during abbreviated new drug 
application assessment and after issuance of a complete response letter 
or a tentative approval or approval); providing additional 
recommendations on requests for information related to inactive 
ingredients; and other updates that are intended to clarify FDA's 
recommendations to industry.
    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 ``Controlled 
Correspondence Related to Generic Drug Development.'' 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

    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 parts 312 and 314 have been approved under OMB 
control numbers 0910-0014 and 0910-0797, respectively.

III. Electronic Access

    Persons with access to the internet may obtain 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: December 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27827 Filed 12-21-22; 8:45 am]
BILLING CODE 4164-01-P
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