Agency Information Collection Activities; Proposed Collection; Comment Request; Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded-Time and Extent Applications for Nonprescription Drug Products, 45892-45894 [2020-16528]
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<![CDATA[
45892
Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section; activity
80.39; Record of distribution .............
1 There
38
Dated: July 23, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–16534 Filed 7–29–20; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket No. FDA–2010–N–0493]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Additional Criteria
and Procedures for Classifying Overthe-Counter Drugs as Generally
Recognized as Safe and Effective and
Not Misbranded—Time and Extent
Applications for Nonprescription Drug
Products
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the collection of
information associated with the criteria
and procedures for classifying over-thecounter (OTC) drugs as generally
recognized as safe and effective and not
misbranded.
DATES: Submit either electronic or
written comments on the collection of
information by September 28, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
SUMMARY:
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198
7,524
Average burden per recordkeeping
0.25 (15 minutes) .............................
VerDate Sep<11>2014
16:38 Jul 29, 2020
Jkt 250001
be submitted on or before September 28,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 28, 2020.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Total annual
records
Total hours
1,881
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
AGENCY:
Number of
records per
recordkeeper
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.’’
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
Instructions: All submissions received
must include Docket No. FDA–2010–N–
0493 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Additional Criteria and Procedures for
Classifying Over-the-Counter Drugs as
Generally Recognized as Safe and
Effective and Not Misbranded; Guidance
for Industry—Time and Extent
Applications for Nonprescription Drug
Product.’’ 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.’’ 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
E:\FR\FM\30JYN1.SGM
30JYN1
Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Notices
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:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
khammond on DSKJM1Z7X2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
16:38 Jul 29, 2020
Jkt 250001
Additional Criteria and Procedures for
Classifying Over-the-Counter Drugs as
Generally Recognized as Safe and
Effective and Not Misbranded—Time
and Extent Applications for
Nonprescription Drug Products (21 CFR
330.14)
OMB Control Number 0910–0688—
Extension
This information collection supports
Agency regulations and associated
guidance. Specifically, FDA regulations
in § 330.14 (21 CFR 330.14) establish
additional criteria and procedures for
classifying OTC drugs as generally
recognized as safe and effective and not
misbranded. These regulations state that
OTC drug products introduced into the
U.S. market after the OTC drug review
began in 1972 and OTC drug products
without any marketing experience in the
United States can be evaluated under
the monograph process if the conditions
(e.g., active ingredients) meet certain
‘‘time and extent’’ criteria outlined in
the regulations. The regulations allow a
time and extent application (TEA) to be
submitted to us by any party for our
consideration to include new conditions
in the OTC drug monograph system.
TEAs must provide evidence
described in § 330.14(c) demonstrating
that the condition is eligible for
inclusion in the monograph system.
(Section 330.14(d) specifies the number
of copies and address for submission of
a TEA.) If a condition is found eligible,
any interested parties can submit safety
and effectiveness information as
explained in § 330.14(f). Safety and
effectiveness data include the data and
information listed in 21 CFR
330.10(a)(2), a listing of all serious
adverse drug experiences that may have
occurred (§ 330.14(f)(2)), and an official
or proposed compendial monograph
(§ 330.14(i)).
Based on our experience with
submissions we have received under
§ 330.14, we estimate that we will
receive 2 TEAs and 2 safety and
effectiveness submissions each year and
assume that it will take 1,525 hours to
prepare a TEA and 2,350 hours to
prepare a comprehensive safety and
effectiveness submission.
We revised our regulations in part 330
(21 CFR part 330) (81 FR 84465,
November 23, 2016), thus adding 6
hours to our estimated annual reporting
burden for the information collection.
Specifically, § 330.14(j) clarifies the
requirements on content and format
criteria for a safety and effectiveness
data submission and provides
procedures for our review of the
submissions and determination of
PO 00000
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Fmt 4703
Sfmt 4703
45893
whether a submission is sufficiently
complete to permit a substantive review.
Section 330.14(j)(3) describes the
process for cases in which we refuse to
file the safety and effectiveness data
submission. Under § 330.14(j)(3), if we
refuse to file the submission, we will
notify the sponsor in writing, state the
reason(s) for the refusal, and allow the
sponsor 30 days to submit a written
request for an informal conference with
us about whether we should file the
submission. We estimate one
respondent will submit a request for an
informal conference each year and
assume that preparing and submitting
each request will take 1 hour.
Under § 330.14(j)(4)(iii), the safety
and effectiveness data submission must
contain a signed statement that the
submission represents a complete safety
and effectiveness data submission and
that the submission includes all the
safety and effectiveness data and
information available to the sponsor at
the time of the submission, whether
positive or negative. We estimate that
two respondents will submit such
signed statements each year and assume
that preparing and submitting each
signed statement takes 1 hour.
Under § 330.14(k)(1), we, in response
to a written request from a sponsor, may
withdraw consideration of a TEA
submitted under § 330.14(c) or a safety
and effectiveness data submission under
§ 330.14(f). We estimate that one
respondent will submit such a request
each year and assume that preparing
and submitting the request takes 1 hour.
Under § 330.14(k)(2), a sponsor may
request that FDA not withdraw
consideration of a TEA or safety and
effectiveness data submission. We
estimate one respondent will submit
such a request each year and assume
that preparing and submitting the
request takes 2 hours.
To assist respondents with the
information collection, we developed
the guidance document entitled, ‘‘Time
and Extent Applications for
Nonprescription Drug Products,’’ issued
consistent with our Good Guidance
Practice regulations at 21 CFR 10.115
which provide for comment at any time,
and available from our website at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/time-and-extentapplications-nonprescription-drugproducts. The guidance explains what
information an applicant should submit
to FDA to request that a drug product be
included in the OTC drug monograph
system and describes the process for
submitting that information.
We estimate the burden of this
collection of information as follows:
E:\FR\FM\30JYN1.SGM
30JYN1
45894
Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Time and extent application and submission of information
(§ 330.14(c) and (d)) .........................................................
Safety and effectiveness data (§ 330.14(f) and (i)) .............
Sponsor
request
for
an
informal
conference
(§ 330.14(j)(3)) ..................................................................
Sponsor signed statement that submission is complete
(§ 330.14(j)(4)) ..................................................................
Sponsor request for FDA to withdraw TEA consideration
(§ 330.14(k)(1)) .................................................................
Sponsor request for FDA not to deem the submission
withdrawn (§ 330.14(k)(2)) ................................................
Total ..............................................................................
1 There
Dated: July 23, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
1
1
2
2
1,525
2,350
3,050
4,700
1
1
1
1
1
2
1
2
1
2
1
1
1
1
1
1
1
1
2
2
........................
........................
........................
........................
7,756
submitting new drug applications
(NDAs), biologics license applications
(BLAs) (for biological products that are
regulated as drugs), and efficacy
supplements to approved NDAs or
BLAs.
Submit either electronic or
written comments on the draft guidance
by September 28, 2020 to ensure that
the Agency considers your comment on
this draft guidance before it begins work
on the final version of the guidance.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
You may submit comments
on any guidance at any time as follows:
[Docket No. FDA–2014–D–1551]
Electronic Submissions
Pregnancy, Lactation, and
Reproductive Potential: Labeling for
Human Prescription Drug and
Biological Products—Content and
Format; Draft Guidance for Industry;
Availability
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’’).
ADDRESSES:
Food and Drug Administration,
HHS.
ACTION:
Total hours
2
2
DATES:
[FR Doc. 2020–16528 Filed 7–29–20; 8:45 am]
AGENCY:
Average
burden per
response
Total annual
responses
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Pregnancy, Lactation, and
Reproductive Potential: Labeling for
Human Prescription Drug and Biological
Products—Content and Format.’’ This
draft guidance is intended to assist
applicants in complying with the
content and format requirements of the
Pregnancy, Lactation, and Females and
Males of Reproductive Potential
subsections of labeling for human
prescription drug and biological
products. This draft guidance revises
the draft guidance issued in December
2014. This revision provides
clarification and additional information
on recommendations to applicants
SUMMARY:
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Number of
responses per
respondent
Number of
respondents
21 CFR part and activity
VerDate Sep<11>2014
16:38 Jul 29, 2020
Jkt 250001
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
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–1551 for ‘‘Pregnancy, Lactation,
and Reproductive Potential: Labeling for
Human Prescription Drug and Biological
Products—Content and Format.’’
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.
• 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
E:\FR\FM\30JYN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 147 (Thursday, July 30, 2020)]
[Notices]
[Pages 45892-45894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16528]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0493]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Additional Criteria and Procedures for Classifying
Over-the-Counter Drugs as Generally Recognized as Safe and Effective
and Not Misbranded--Time and Extent Applications for Nonprescription
Drug Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the collection of information associated
with the criteria and procedures for classifying over-the-counter (OTC)
drugs as generally recognized as safe and effective and not misbranded.
DATES: Submit either electronic or written comments on the collection
of information by September 28, 2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before September 28, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 28, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is 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 Docket No. FDA-
2010-N-0493 for ``Agency Information Collection Activities; Proposed
Collection; Comment Request; Additional Criteria and Procedures for
Classifying Over-the-Counter Drugs as Generally Recognized as Safe and
Effective and Not Misbranded; Guidance for Industry--Time and Extent
Applications for Nonprescription Drug Product.'' 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.'' 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
[[Page 45893]]
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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Additional Criteria and Procedures for Classifying Over-the-Counter
Drugs as Generally Recognized as Safe and Effective and Not
Misbranded--Time and Extent Applications for Nonprescription Drug
Products (21 CFR 330.14)
OMB Control Number 0910-0688--Extension
This information collection supports Agency regulations and
associated guidance. Specifically, FDA regulations in Sec. 330.14 (21
CFR 330.14) establish additional criteria and procedures for
classifying OTC drugs as generally recognized as safe and effective and
not misbranded. These regulations state that OTC drug products
introduced into the U.S. market after the OTC drug review began in 1972
and OTC drug products without any marketing experience in the United
States can be evaluated under the monograph process if the conditions
(e.g., active ingredients) meet certain ``time and extent'' criteria
outlined in the regulations. The regulations allow a time and extent
application (TEA) to be submitted to us by any party for our
consideration to include new conditions in the OTC drug monograph
system.
TEAs must provide evidence described in Sec. 330.14(c)
demonstrating that the condition is eligible for inclusion in the
monograph system. (Section 330.14(d) specifies the number of copies and
address for submission of a TEA.) If a condition is found eligible, any
interested parties can submit safety and effectiveness information as
explained in Sec. 330.14(f). Safety and effectiveness data include the
data and information listed in 21 CFR 330.10(a)(2), a listing of all
serious adverse drug experiences that may have occurred (Sec.
330.14(f)(2)), and an official or proposed compendial monograph (Sec.
330.14(i)).
Based on our experience with submissions we have received under
Sec. 330.14, we estimate that we will receive 2 TEAs and 2 safety and
effectiveness submissions each year and assume that it will take 1,525
hours to prepare a TEA and 2,350 hours to prepare a comprehensive
safety and effectiveness submission.
We revised our regulations in part 330 (21 CFR part 330) (81 FR
84465, November 23, 2016), thus adding 6 hours to our estimated annual
reporting burden for the information collection. Specifically, Sec.
330.14(j) clarifies the requirements on content and format criteria for
a safety and effectiveness data submission and provides procedures for
our review of the submissions and determination of whether a submission
is sufficiently complete to permit a substantive review.
Section 330.14(j)(3) describes the process for cases in which we
refuse to file the safety and effectiveness data submission. Under
Sec. 330.14(j)(3), if we refuse to file the submission, we will notify
the sponsor in writing, state the reason(s) for the refusal, and allow
the sponsor 30 days to submit a written request for an informal
conference with us about whether we should file the submission. We
estimate one respondent will submit a request for an informal
conference each year and assume that preparing and submitting each
request will take 1 hour.
Under Sec. 330.14(j)(4)(iii), the safety and effectiveness data
submission must contain a signed statement that the submission
represents a complete safety and effectiveness data submission and that
the submission includes all the safety and effectiveness data and
information available to the sponsor at the time of the submission,
whether positive or negative. We estimate that two respondents will
submit such signed statements each year and assume that preparing and
submitting each signed statement takes 1 hour.
Under Sec. 330.14(k)(1), we, in response to a written request from
a sponsor, may withdraw consideration of a TEA submitted under Sec.
330.14(c) or a safety and effectiveness data submission under Sec.
330.14(f). We estimate that one respondent will submit such a request
each year and assume that preparing and submitting the request takes 1
hour.
Under Sec. 330.14(k)(2), a sponsor may request that FDA not
withdraw consideration of a TEA or safety and effectiveness data
submission. We estimate one respondent will submit such a request each
year and assume that preparing and submitting the request takes 2
hours.
To assist respondents with the information collection, we developed
the guidance document entitled, ``Time and Extent Applications for
Nonprescription Drug Products,'' issued consistent with our Good
Guidance Practice regulations at 21 CFR 10.115 which provide for
comment at any time, and available from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/time-and-extent-applications-nonprescription-drug-products. The guidance
explains what information an applicant should submit to FDA to request
that a drug product be included in the OTC drug monograph system and
describes the process for submitting that information.
We estimate the burden of this collection of information as
follows:
[[Page 45894]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR part and activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Time and extent application and 2 1 2 1,525 3,050
submission of information (Sec.
330.14(c) and (d))...........
Safety and effectiveness data 2 1 2 2,350 4,700
(Sec. 330.14(f) and (i)).....
Sponsor request for an informal 1 1 1 1 1
conference (Sec.
330.14(j)(3))..................
Sponsor signed statement that 2 1 2 1 2
submission is complete (Sec.
330.14(j)(4))..................
Sponsor request for FDA to 1 1 1 1 1
withdraw TEA consideration
(Sec. 330.14(k)(1))..........
Sponsor request for FDA not to 1 1 1 2 2
deem the submission withdrawn
(Sec. 330.14(k)(2))..........
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Total....................... .............. .............. .............. .............. 7,756
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: July 23, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16528 Filed 7-29-20; 8:45 am]
BILLING CODE 4164-01-P
