Controlled Correspondence Related to Generic Drug Development; Guidance for Industry; Availability, 81928-81929 [2020-27810]

Download as PDF 81928 Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Notices INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Wiley A. Chambers, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 22, Rm. 6108, Silver Spring, MD 20993, 301–796– 0690. DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTARY INFORMATION: AGENCY: Controlled Correspondence Related to Generic Drug Development; Guidance for Industry; Availability ACTION: FDA is announcing the availability of a draft guidance for industry entitled ‘‘Dry Eye: Developing Drugs for Treatment.’’ Dry eye disease is a common condition, particularly in older individuals. Signs and symptoms of dry eye disease can cause interference with activities of daily living. This draft guidance document, once finalized, will help developers of treatments for dry eye disease efficiently develop drugs to treat dry eye conditions. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Dry Eye: Developing Drugs for Treatment.’’ 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– 0001, respectively. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs or https:// www.regulations.gov. Dated: December 14, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–27762 Filed 12–16–20; 8:45 am] BILLING CODE 4164–01–P 18:52 Dec 16, 2020 [Docket No. FDA–2014–D–1167] Food and Drug Administration, HHS. I. Background VerDate Sep<11>2014 Food and Drug Administration Jkt 253001 Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final 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 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 guidance finalizes the draft guidance announced in the Federal Register on November 3, 2017, and replaces the guidance for industry ‘‘Controlled Correspondence Related to Generic Drug Development’’ issued in September 2015. DATES: The announcement of the guidance is published in the Federal Register on December 17, 2020. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: SUMMARY: 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 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 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 E:\FR\FM\17DEN1.SGM 17DEN1 Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Notices 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)). Submit written requests for single copies of this 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 guidance document. FOR FURTHER INFORMATION CONTACT: Lisa Bercu, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 240–402–6902. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a 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 2018–2022 (GDUFA II Goals Letter or GDUFA II Commitment Letter), FDA VerDate Sep<11>2014 18:52 Dec 16, 2020 Jkt 253001 agreed to certain review goals and procedures for the review of controlled correspondence received both before and on or after October 1, 2017. The GDUFA II Commitment Letter also defines standard controlled correspondence and complex controlled correspondence, and the guidance provides additional details and recommendations concerning what inquiries FDA considers controlled correspondence for the purposes of meeting the Agency’s GDUFA II commitment. In addition, the guidance provides details and recommendations concerning what information requestors should include in a controlled correspondence to facilitate FDA’s consideration of and response to the controlled correspondence and what information FDA will provide in its communications to requestors that have submitted controlled correspondence. The GDUFA II Commitment Letter also states that FDA will review and respond to requests to clarify ambiguities in the controlled correspondence response, and the guidance provides information on how requestors may submit these requests and the Agency’s process for responding to them. This guidance finalizes the draft guidance announced in the Federal Register on November 3, 2017 (82 FR 51277), and replaces the guidance for industry ‘‘Controlled Correspondence Related to Generic Drug Development’’ issued in September 2015. The Agency considered comments on the draft guidance while finalizing the guidance. Revisions include clarification on FDA’s practices regarding controlled correspondence that is related to a pending petition, what information should be submitted with a request related to an inactive ingredient, and when FDA may determine an inquiry is a complex controlled correspondence. We also revised the guidance to recommend that requestors submit their controlled correspondence through the CDER Direct NextGen Collaboration Portal. 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 ‘‘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 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 81929 previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (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 0910–0797. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: December 14, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–27810 Filed 12–16–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–0026] Issuance of Priority Review Voucher; Rare Pediatric Disease Product AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that IMCIVREE (setmelanotide) injection, manufactured by Rhythm Pharmaceuticals, Inc., meets the criteria for a priority review voucher. SUMMARY: FOR FURTHER INFORMATION CONTACT: Althea Cuff, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–4061, Fax: 301–796–9856, email: althea.cuff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority review voucher to the sponsor of an E:\FR\FM\17DEN1.SGM 17DEN1

Agencies

[Federal Register Volume 85, Number 243 (Thursday, December 17, 2020)]
[Notices]
[Pages 81928-81929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27810]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Controlled Correspondence Related to Generic Drug Development;
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 final 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 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 guidance
finalizes the draft guidance announced in the Federal Register on
November 3, 2017, and replaces the guidance for industry ``Controlled
Correspondence Related to Generic Drug Development'' issued in
September 2015.

DATES: The announcement of the guidance is published in the Federal
Register on December 17, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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

[[Page 81929]]

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 this 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 guidance document.

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

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a 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
2018-2022 (GDUFA II Goals Letter or GDUFA II Commitment Letter), FDA
agreed to certain review goals and procedures for the review of
controlled correspondence received both before and on or after October
1, 2017. The GDUFA II Commitment Letter also defines standard
controlled correspondence and complex controlled correspondence, and
the guidance provides additional details and recommendations concerning
what inquiries FDA considers controlled correspondence for the purposes
of meeting the Agency's GDUFA II commitment. In addition, the guidance
provides details and recommendations concerning what information
requestors should include in a controlled correspondence to facilitate
FDA's consideration of and response to the controlled correspondence
and what information FDA will provide in its communications to
requestors that have submitted controlled correspondence. The GDUFA II
Commitment Letter also states that FDA will review and respond to
requests to clarify ambiguities in the controlled correspondence
response, and the guidance provides information on how requestors may
submit these requests and the Agency's process for responding to them.
This guidance finalizes the draft guidance announced in the Federal
Register on November 3, 2017 (82 FR 51277), and replaces the guidance
for industry ``Controlled Correspondence Related to Generic Drug
Development'' issued in September 2015. The Agency considered comments
on the draft guidance while finalizing the guidance. Revisions include
clarification on FDA's practices regarding controlled correspondence
that is related to a pending petition, what information should be
submitted with a request related to an inactive ingredient, and when
FDA may determine an inquiry is a complex controlled correspondence. We
also revised the guidance to recommend that requestors submit their
controlled correspondence through the CDER Direct NextGen Collaboration
Portal.
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 ``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 (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 0910-0797.

III. Electronic Access

Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

Dated: December 14, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-27810 Filed 12-16-20; 8:45 am]
BILLING CODE 4164-01-P

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