Cover Letter Attachments for Controlled Correspondences and Abbreviated New Drug Application Submissions; Draft Guidance for Industry; Availability, 70849-70850 [2021-26893]
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Federal Register / Vol. 86, No. 236 / Monday, December 13, 2021 / Notices
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’’).
guidances-drugs or https://
www.regulations.gov.
Dated: December 6, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–26923 Filed 12–10–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–0861]
Cover Letter Attachments for
Controlled Correspondences and
Abbreviated New Drug Application
Submissions; Draft Guidance for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announcing the availability of a draft
guidance for industry entitled ‘‘Cover
Letter Attachments for Controlled
Correspondences and Abbreviated New
Drug Application Submissions.’’ This
guidance is intended to assist
prospective applicants, applicants, and
holders of abbreviated new drug
applications (ANDAs) with optional
attachments that can be used when
preparing cover letters that accompany
controlled correspondence to the Office
of Generic Drugs (OGD), as well as
original ANDAs, amendments to
ANDAs, and supplements to approved
ANDAs submitted to FDA.
DATES: Submit either electronic or
written comments on the draft guidance
by February 11, 2022 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draft guidance before it begins work on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:
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
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
VerDate Sep<11>2014
16:50 Dec 10, 2021
Jkt 256001
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–
2021–D–0861 for ‘‘Cover Letter
Attachments for Controlled
Correspondences and ANDA
Submissions.’’ 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
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
70849
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)).
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:
Nicole Park, Office of Generic Drugs,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Rm. 1725, Silver Spring, MD
20993–0002, 240–402–7764,
Nicole.Park@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Cover Letter Attachments for
Controlled Correspondences and ANDA
Submissions.’’ This guidance is
intended to assist prospective
applicants, applicants, and holders of
ANDAs with optional attachments that
can be used when preparing cover
letters that accompany controlled
correspondence to OGD, as well as
original ANDAs, amendments to
ANDAs, and supplements to approved
ANDAs submitted to FDA.
A cover letter is generally included
with controlled correspondence to OGD
and submissions to an ANDA file. While
a cover letter is not required content for
an ANDA, the cover letter is a part of
the electronic common technical
E:\FR\FM\13DEN1.SGM
13DEN1
70850
Federal Register / Vol. 86, No. 236 / Monday, December 13, 2021 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
document (eCTD) hierarchy and is
included in Module 1 of an ANDA
submission.
The cover letter provides an overview
of the submission and helps FDA ensure
that the submission is properly triaged
and assigned to the appropriate
assessors. In an effort to ensure that
submissions are effectively managed by
FDA and acted upon within the
performance review goal dates set by the
Generic Drug User Fee Amendments,
FDA has developed cover letter
attachments to accompany, not replace,
applicants’ cover letters for common
submissions, including controlled
correspondence, original ANDAs and
amendments to ANDAs, as well as
supplements to approved ANDAs.
These cover letter attachments have
been designed as a checklist to reflect
common types of information applicants
are expected to address in their cover
letters. The attachments are intended
both to serve as a useful guide to help
applicants prepare their cover letters,
and to assist FDA in the triage and
management of submissions.
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 ‘‘Cover Letter Attachments for
Controlled Correspondences and ANDA
Submissions.’’ 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 part 314
(including subpart C) for to the content
and format of ANDAs, including
original ANDAs, amendments to
ANDAs, and supplements to approved
ANDAs, submitted by applicants and
approved by FDA have been approved
under OMB control number 0910–0001.
The collections of information for Form
FDA 356h (NDA and ANDA cover letter)
have been approved under OMB control
number 0910–0338.
Applicants submit to FDA controlled
correspondence along with cover letters
related to generic drug development and
VerDate Sep<11>2014
16:50 Dec 10, 2021
Jkt 256001
FDA approval. Such submissions have
been approved under OMB control
number 0910–0797. The collections of
information in 21 CFR part 11 for
electronic records and electronic
signatures have been approved under
OMB control number 0910–0303. The
collections of information in 21 CFR
part 211 about the manufacture of the
drug have been approved under OMB
control number 0910–0139.
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-fdaguidance-documents, or https://
www.regulations.gov.
Dated: December 6, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–26893 Filed 12–10–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–1301]
Q3C(R8) Impurities: Guidance for
Residual Solvents; International
Council for Harmonisation; 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 final
guidance for industry entitled ‘‘Q3C(R8)
Impurities: Guidance for Residual
Solvents.’’ The guidance was prepared
under the auspices of the International
Council for Harmonisation (ICH),
formerly the International Conference
on Harmonisation. This guidance
provides recommendations for
permitted daily exposures (PDEs) for
three additional residual solvents: 2Methyltetrahydrofuran, cyclopentyl
methyl ether, and tert-butyl alcohol. The
PDEs were developed according to the
methods for establishing exposure limits
included in the guidance for industry
‘‘Q3C: Impurities Residual Solvents’’
(Q3C guidance). The Q3C PDE levels are
added and revised as new toxicological
data for solvents become available. This
guidance finalizes the draft guidance
entitled ‘‘Q3C(R8) Recommendations for
the Permitted Daily Exposures for Three
Solvents—2-Methyltetrahydrofuran,
SUMMARY:
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Cyclopentyl Methyl Ether, and TertButyl Alcohol—According to the
Maintenance Procedures for the
Guidance Q3C Impurities: Residual
Solvents’’ issued on May 27, 2020.
DATES: The announcement of the
guidance is published in the Federal
Register on December 13, 2021.
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–
2020–D–1301 for ‘‘Q3C(R8) Impurities:
Guidance for Residual Solvents.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
E:\FR\FM\13DEN1.SGM
13DEN1
]]>Agencies
[Federal Register Volume 86, Number 236 (Monday, December 13, 2021)]
[Notices]
[Pages 70849-70850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26893]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-0861]
Cover Letter Attachments for Controlled Correspondences and
Abbreviated New Drug Application Submissions; 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 ``Cover
Letter Attachments for Controlled Correspondences and Abbreviated New
Drug Application Submissions.'' This guidance is intended to assist
prospective applicants, applicants, and holders of abbreviated new drug
applications (ANDAs) with optional attachments that can be used when
preparing cover letters that accompany controlled correspondence to the
Office of Generic Drugs (OGD), as well as original ANDAs, amendments to
ANDAs, and supplements to approved ANDAs submitted to FDA.
DATES: Submit either electronic or written comments on the draft
guidance by February 11, 2022 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-2021-D-0861 for ``Cover Letter Attachments for Controlled
Correspondences and ANDA Submissions.'' 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: Nicole Park, Office of Generic Drugs,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Rm. 1725, Silver Spring, MD 20993-0002, 240-
402-7764, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Cover Letter Attachments for Controlled Correspondences and
ANDA Submissions.'' This guidance is intended to assist prospective
applicants, applicants, and holders of ANDAs with optional attachments
that can be used when preparing cover letters that accompany controlled
correspondence to OGD, as well as original ANDAs, amendments to ANDAs,
and supplements to approved ANDAs submitted to FDA.
A cover letter is generally included with controlled correspondence
to OGD and submissions to an ANDA file. While a cover letter is not
required content for an ANDA, the cover letter is a part of the
electronic common technical
[[Page 70850]]
document (eCTD) hierarchy and is included in Module 1 of an ANDA
submission.
The cover letter provides an overview of the submission and helps
FDA ensure that the submission is properly triaged and assigned to the
appropriate assessors. In an effort to ensure that submissions are
effectively managed by FDA and acted upon within the performance review
goal dates set by the Generic Drug User Fee Amendments, FDA has
developed cover letter attachments to accompany, not replace,
applicants' cover letters for common submissions, including controlled
correspondence, original ANDAs and amendments to ANDAs, as well as
supplements to approved ANDAs. These cover letter attachments have been
designed as a checklist to reflect common types of information
applicants are expected to address in their cover letters. The
attachments are intended both to serve as a useful guide to help
applicants prepare their cover letters, and to assist FDA in the triage
and management of submissions.
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 ``Cover Letter
Attachments for Controlled Correspondences and ANDA Submissions.'' 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 part 314 (including subpart C) for to the
content and format of ANDAs, including original ANDAs, amendments to
ANDAs, and supplements to approved ANDAs, submitted by applicants and
approved by FDA have been approved under OMB control number 0910-0001.
The collections of information for Form FDA 356h (NDA and ANDA cover
letter) have been approved under OMB control number 0910-0338.
Applicants submit to FDA controlled correspondence along with cover
letters related to generic drug development and FDA approval. Such
submissions have been approved under OMB control number 0910-0797. The
collections of information in 21 CFR part 11 for electronic records and
electronic signatures have been approved under OMB control number 0910-
0303. The collections of information in 21 CFR part 211 about the
manufacture of the drug have been approved under OMB control number
0910-0139.
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 6, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26893 Filed 12-10-21; 8:45 am]
BILLING CODE 4164-01-P
