Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Food and Drug Administration Approval To Market a New Drug, 9510-9512 [2021-03023]
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Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2030]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Application for
Food and Drug Administration
Approval To Market a New Drug
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.
DATES: Submit written comments
(including recommendations) on the
collection of information by March 18,
2021.
ADDRESSES: 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 0910–0001. Also include
the FDA docket number found in
brackets in the heading of this
document.
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.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
Application for FDA Approval To
Market a New Drug; OMB Control No.
0910–0001—Revision
This information collection supports
FDA regulations. Under section 505(a)
of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 355(a)), a
new drug may not be commercially
marketed in the United States unless an
approval of an application filed with
FDA under section 505(b) or (j) of the
FD&C Act is effective with respect to
such drug. We have issued regulations
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in part 314 (21 CFR part 314) to govern
procedures and requirements for
applications submitted in accordance
with section 505. The regulations in
subpart A (§§ 314.1 through 314.3) set
forth general provisions, while
regulations in subparts B and C
(§§ 314.50 through 314.99) set forth
content and format requirements for
new drug applications (NDAs) and
abbreviated new drug applications
(ANDAs) respectively. The regulations
include requirements for the submission
of specific data elements along with
patent information, pediatric use
information, supplements and
amendments, proposed labeling, and
specific postmarketing reports.
Respondents to the information
collection are sponsors of these
applications.
To assist respondents to the
information collection we have
developed the following forms:
• Form FDA 0356h (and instructions):
Application to Market a New or
Abbreviated New Drug or Biologic for
Human Use;
• Form FDA 2252 (and instructions):
Transmittal of Annual Reports for Drugs
and Biologics For Human Use
(§ 314.81);
• Form FDA 2253 (and instructions):
Transmittal of Advertisements and
Promotional Labeling For Drugs and
Biologics For Human Use; and
• Forms FDA 3331/3331a: Field Alert
Report and Instruction
• Forms FDA 3542 and 3542a and
Instructions: Patent Information
Submitted Upon and After Approval of
an NDA Supplement; Patent
Information Submitted With the Filing
of an NDA, Amendment, or Supplement
• New Draft Form FDA 3898 and
Instruction: Drug Master File
Individuals requesting printed forms
are instructed to contact the FDA Forms
Manager by email at formsmanager@
OC.FDA.GOV. Certain fees may be
applicable.
Regulations in subpart D (§§ 314.100
through 314.170) explain Agency
actions on applications and set forth
timeframes for FDA review. We are
revising the information collection to
include provisions established through
our Agency user fee programs, most
recently authorized under the FDA
Reauthorization Act of 2017. These
provisions pertain to review
transparency, communications with
FDA, dispute resolution, drug safety
enhancements, and the allocation of
Agency resources to align with these
program objectives as agreed to with our
stakeholders and set forth in our
‘‘Performance Goals for Fiscal Years
2018–2022’’ Commitment Letters, which
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are available from our website at https://
www.fda.gov along with more
information about FDA user fee
programs.
Information collection pertaining to
hearing and other administrative
proceedings covered in 21 CFR subpart
E are approved under OMB control no.
0910–0191. Unless otherwise noted,
information collection pertaining to
postmarket safety reporting and
associated recordkeeping is approved
under OMB control nos. 0910–0230,
0910–0291, and 0910–0645.
Included among the miscellaneous
provisions in subpart G (§§ 314.410 to
314.445), § 314.420 covers information
to include in drug master files (DMFs).
To assist respondents to this
information collection we have
prepared templates and resources
available from our website at
www.fda.gov/drugs/forms-submissionrequirements/drug-master-files-dmfs. As
noted above, we have developed new
Form FDA 3898 and accompanying
instructions on submitting DMFs in
accordance with the applicable
regulations. In accordance with
§ 314.445, we also develop Agency
guidance documents to assist
respondents in complying with
provisions in part 314. These guidance
documents are issued consistent with
our good guidance practice regulations
at § 10.115. To search available FDA
guidance documents, visit our website
at https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Finally, applications
submitted in accordance with subpart H
(§§ 314.500 through 314.560) pertain to
accelerated approval of new drugs for
serious or life-threatening illness, and
submissions in subpart I (§§ 314.600
through 314.650) pertain to approval of
new drugs when human efficacy studies
are not ethical or feasible. The
regulations provide for the submission
of specific data elements along with
promotional material.
We use the information collection to
approve drugs shown to be safe and
effective and to implement effective
public health monitoring systems. We
also use product approval and related
patent and exclusivity information to
publish the ‘‘Approved Drug Products
with Therapeutic Equivalence
Evaluations’’ list (the Orange Book).
More information regarding the Orange
Book is available from our website at
https://www.fda.gov/drugs/drugapprovals-and-databases/approveddrug-products-therapeutic-equivalenceevaluations-orange-book.
In the Federal Register of November
16, 2020 (85 FR 73057), we published a
60-day notice requesting public
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Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices
comment on the proposed collection of
information. No comments were
received and we have therefore made no
adjustments to our estimate, which is as
follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
responses per
respondent
Number of
respondents
21 CFR section
Average
burden
per response
(in hours)
Total annual
responses
Total hours
Subpart B
314.50(a)–(l)—Content and format of a 505(b)(1) or
505(b)(2) application ........................................................
314.50(i)(1)—patent certifications:
Form FDA 3542 ............................................................
Form FDA 3542a ..........................................................
314.50(i)(6) amended patent certifications ..........................
314.52(a), (b), and (e)—NDAs—notice of noninfringement
of patent certification ........................................................
314.52(c)—Noninfringement of patent certification notice
content ..............................................................................
314.53(f)(1)—Correction of patent information errors by
persons other than the NDA holder .................................
314.53(f)(2)—Correction of patent information errors by
the NDA holder .................................................................
314.60—Amendments to unapproved NDA, supplement or
resubmission ....................................................................
314.60(f)—patent certifications for unapproved applications ..................................................................................
314.65—Withdrawal of unapproved applications ................
314.70 and 314.71—Supplements and other changes to
approved application ........................................................
314.72—Changes of ownership of NDAs ............................
314.81—Other postmarketing reports 314.81(b)(1) [3331
and 3331a field alert reports and followups] ....................
314.81(b)(2)[2252]—Annual reports ....................................
314.81(b)(2)[2253]—Promotional labeling ...........................
121
1.15
139
1,921
267,019
281
310
17
2.875
2.084
1
808
646
17
10
15
2
8,080
9,690
34
15
3
45
15
675
22
3
66
0.33 (20
minutes)
22
24
1
24
10
240
28
1.4
39
1
39
256
8.23
2,106
80
168,480
6
14
1
1.21
6
17
2
2
12
34
492
67
6.57
1.45
3,232
97
150
2
484,800
194
484
626
331
20.3
4.9
141.3
9,834
3,066
46,782
8
40
2
78,672
122,640
93,564
Subpart C
314.94(a)and(d)—ANDA content .........................................
314.94(a)(12)(viii) amended patent certifications before approval of ANDA ................................................................
314.95(c)—Non-infringement of patents (ANDAs) ..............
229
4.3
987
480
473,760
153
400
1
3
153
1,200
306
400
314.96(a)(1)—Amendments to unapproved ANDAs ...........
314.96(c) amendment for pharmaceutical equivalent to a
listed drug other than RLD ...............................................
314.96(d)—patent certification requirements .......................
314.97—Supplements and other changes to ANDAs .........
314.97(b) Supplements to ANDA for pharmaceutical
equivalent to a listed drug other than RLD ......................
314.99(a)—ANDA Applicants: Withdrawal of unapproved
ANDAs ..............................................................................
314.99(a)—ANDA Transfer of ownership ............................
451
36.2
16,311
2
0.33 (20
minutes)
80
1,304,880
1
100
361
1
1
22.8
1
100
8,237
300
2
80
300
200
658,960
1
1
1
300
300
77
135
2.3
1.24
177
167
2
2
354
334
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Subpart D
314.101(a)—NDA or ANDA filing over protest ....................
1
1
1
0.5 (30
minutes)
0.5
314.107(e)—notification of court actions or written consent
to approval ........................................................................
247
2
494
0.5 (30
minutes)
247
Subparts G, H, and I
314.420—drug master files [FDA 3938]—original amendments ................................................................................
DMFs—technical, administrative, REMS) ............................
DMFs—annual reports .........................................................
314.550—Promotional material and subpart H applications
36
2,946
2,946
55
27.2
11.4
3.33
11.6
981
33,590
9,834
640
61
8
4
120
59,841
268,720
39,336
76,800
Total ..............................................................................
........................
........................
........................
........................
4,118,933.5
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Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices
Our estimated burden for the
information collection reflects a
decrease. We attribute this adjustment
to improved operational efficiencies
with regard to Agency data systems and
digital submission processes.
Dated: February 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–03023 Filed 2–12–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0134]
Joint Meeting of the Arthritis Advisory
Committee and the Drug Safety and
Risk Management Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Arthritis Advisory
Committee and the Drug Safety and Risk
Management Advisory Committee. The
general function of the committees is to
provide advice and recommendations to
FDA on regulatory issues. The meeting
will be open to the public. FDA is
establishing a docket for public
comment on this document.
DATES: The meeting will be held on
March 24, 2021, from 9 a.m. to 4:30 p.m.
Eastern Time and March 25, 2021, from
10 a.m. to 1 p.m. Eastern Time.
ADDRESSES: Please note that due to the
impact of this COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform.
Answers to commonly asked questions
about FDA advisory committee meetings
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2021–N–0134.
The docket will close on March 23,
2021. Submit either electronic or
written comments on this public
meeting by March 23, 2021. Please note
that late, untimely filed comments will
not be considered. Electronic comments
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
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must be submitted on or before March
23, 2021. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
March 23, 2021. 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.
Comments received on or before
March 10, 2021, will be provided to the
committees. Comments received after
that date will be taken into
consideration by FDA. In the event that
the meeting is cancelled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
You may submit comments 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
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identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2021–N–0134 for ‘‘Joint Meeting of the
Arthritis Advisory Committee and the
Drug Safety and Risk Management
Advisory Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ FDA
will review this copy, including the
claimed confidential information, in its
consideration of comments. The second
copy, which will have the claimed
confidential information redacted/
blacked out, will be available for public
viewing and posted on https://
www.regulations.gov. Submit both
copies to the Dockets Management Staff.
If you do not wish your name and
contact information 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 the 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.
FOR FURTHER INFORMATION CONTACT:
Moon Hee V. Choi, Center for Drug
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]]>Agencies
[Federal Register Volume 86, Number 29 (Tuesday, February 16, 2021)]
[Notices]
[Pages 9510-9512]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03023]
[[Page 9510]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2030]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Application for Food
and Drug Administration Approval To Market a New Drug
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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.
DATES: Submit written comments (including recommendations) on the
collection of information by March 18, 2021.
ADDRESSES: 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 0910-0001. Also include the FDA docket
number found in brackets in the heading of this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Application for FDA Approval To Market a New Drug; OMB Control No.
0910-0001--Revision
This information collection supports FDA regulations. Under section
505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 355(a)), a new drug may not be commercially marketed in the
United States unless an approval of an application filed with FDA under
section 505(b) or (j) of the FD&C Act is effective with respect to such
drug. We have issued regulations in part 314 (21 CFR part 314) to
govern procedures and requirements for applications submitted in
accordance with section 505. The regulations in subpart A (Sec. Sec.
314.1 through 314.3) set forth general provisions, while regulations in
subparts B and C (Sec. Sec. 314.50 through 314.99) set forth content
and format requirements for new drug applications (NDAs) and
abbreviated new drug applications (ANDAs) respectively. The regulations
include requirements for the submission of specific data elements along
with patent information, pediatric use information, supplements and
amendments, proposed labeling, and specific postmarketing reports.
Respondents to the information collection are sponsors of these
applications.
To assist respondents to the information collection we have
developed the following forms:
Form FDA 0356h (and instructions): Application to Market a
New or Abbreviated New Drug or Biologic for Human Use;
Form FDA 2252 (and instructions): Transmittal of Annual
Reports for Drugs and Biologics For Human Use (Sec. 314.81);
Form FDA 2253 (and instructions): Transmittal of
Advertisements and Promotional Labeling For Drugs and Biologics For
Human Use; and
Forms FDA 3331/3331a: Field Alert Report and Instruction
Forms FDA 3542 and 3542a and Instructions: Patent
Information Submitted Upon and After Approval of an NDA Supplement;
Patent Information Submitted With the Filing of an NDA, Amendment, or
Supplement
New Draft Form FDA 3898 and Instruction: Drug Master File
Individuals requesting printed forms are instructed to contact the
FDA Forms Manager by email at [email protected]. Certain fees may
be applicable.
Regulations in subpart D (Sec. Sec. 314.100 through 314.170)
explain Agency actions on applications and set forth timeframes for FDA
review. We are revising the information collection to include
provisions established through our Agency user fee programs, most
recently authorized under the FDA Reauthorization Act of 2017. These
provisions pertain to review transparency, communications with FDA,
dispute resolution, drug safety enhancements, and the allocation of
Agency resources to align with these program objectives as agreed to
with our stakeholders and set forth in our ``Performance Goals for
Fiscal Years 2018-2022'' Commitment Letters, which are available from
our website at https://www.fda.gov along with more information about
FDA user fee programs.
Information collection pertaining to hearing and other
administrative proceedings covered in 21 CFR subpart E are approved
under OMB control no. 0910-0191. Unless otherwise noted, information
collection pertaining to postmarket safety reporting and associated
recordkeeping is approved under OMB control nos. 0910-0230, 0910-0291,
and 0910-0645.
Included among the miscellaneous provisions in subpart G
(Sec. Sec. 314.410 to 314.445), Sec. 314.420 covers information to
include in drug master files (DMFs). To assist respondents to this
information collection we have prepared templates and resources
available from our website at www.fda.gov/drugs/forms-submission-requirements/drug-master-files-dmfs. As noted above, we have developed
new Form FDA 3898 and accompanying instructions on submitting DMFs in
accordance with the applicable regulations. In accordance with Sec.
314.445, we also develop Agency guidance documents to assist
respondents in complying with provisions in part 314. These guidance
documents are issued consistent with our good guidance practice
regulations at Sec. 10.115. To search available FDA guidance
documents, visit our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Finally, applications
submitted in accordance with subpart H (Sec. Sec. 314.500 through
314.560) pertain to accelerated approval of new drugs for serious or
life-threatening illness, and submissions in subpart I (Sec. Sec.
314.600 through 314.650) pertain to approval of new drugs when human
efficacy studies are not ethical or feasible. The regulations provide
for the submission of specific data elements along with promotional
material.
We use the information collection to approve drugs shown to be safe
and effective and to implement effective public health monitoring
systems. We also use product approval and related patent and
exclusivity information to publish the ``Approved Drug Products with
Therapeutic Equivalence Evaluations'' list (the Orange Book). More
information regarding the Orange Book is available from our website at
https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book.
In the Federal Register of November 16, 2020 (85 FR 73057), we
published a 60-day notice requesting public
[[Page 9511]]
comment on the proposed collection of information. No comments were
received and we have therefore made no adjustments to our estimate,
which is as follows:
Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
----------------------------------------------------------------------------------------------------------------
Subpart B
----------------------------------------------------------------------------------------------------------------
314.50(a)-(l)--Content and 121 1.15 139 1,921 267,019
format of a 505(b)(1) or
505(b)(2) application..........
314.50(i)(1)--patent
certifications:
Form FDA 3542............... 281 2.875 808 10 8,080
Form FDA 3542a.............. 310 2.084 646 15 9,690
314.50(i)(6) amended patent 17 1 17 2 34
certifications.................
314.52(a), (b), and (e)--NDAs-- 15 3 45 15 675
notice of noninfringement of
patent certification...........
314.52(c)--Noninfringement of 22 3 66 0.33 (20 22
patent certification notice minutes)
content........................
314.53(f)(1)--Correction of 24 1 24 10 240
patent information errors by
persons other than the NDA
holder.........................
314.53(f)(2)--Correction of 28 1.4 39 1 39
patent information errors by
the NDA holder.................
314.60--Amendments to unapproved 256 8.23 2,106 80 168,480
NDA, supplement or resubmission
314.60(f)--patent certifications 6 1 6 2 12
for unapproved applications....
314.65--Withdrawal of unapproved 14 1.21 17 2 34
applications...................
314.70 and 314.71--Supplements 492 6.57 3,232 150 484,800
and other changes to approved
application....................
314.72--Changes of ownership of 67 1.45 97 2 194
NDAs...........................
314.81--Other postmarketing 484 20.3 9,834 8 78,672
reports 314.81(b)(1) [3331 and
3331a field alert reports and
followups].....................
314.81(b)(2)[2252]--Annual 626 4.9 3,066 40 122,640
reports........................
314.81(b)(2)[2253]--Promotional 331 141.3 46,782 2 93,564
labeling.......................
----------------------------------------------------------------------------------------------------------------
Subpart C
----------------------------------------------------------------------------------------------------------------
314.94(a)and(d)--ANDA content... 229 4.3 987 480 473,760
314.94(a)(12)(viii) amended 153 1 153 2 306
patent certifications before
approval of ANDA...............
314.95(c)--Non-infringement of 400 3 1,200 0.33 (20 400
patents (ANDAs)................ minutes)
314.96(a)(1)--Amendments to 451 36.2 16,311 80 1,304,880
unapproved ANDAs...............
314.96(c) amendment for 1 1 1 300 300
pharmaceutical equivalent to a
listed drug other than RLD.....
314.96(d)--patent certification 100 1 100 2 200
requirements...................
314.97--Supplements and other 361 22.8 8,237 80 658,960
changes to ANDAs...............
314.97(b) Supplements to ANDA 1 1 1 300 300
for pharmaceutical equivalent
to a listed drug other than RLD
314.99(a)--ANDA Applicants: 77 2.3 177 2 354
Withdrawal of unapproved ANDAs.
314.99(a)--ANDA Transfer of 135 1.24 167 2 334
ownership......................
----------------------------------------------------------------------------------------------------------------
Subpart D
----------------------------------------------------------------------------------------------------------------
314.101(a)--NDA or ANDA filing 1 1 1 0.5 (30 0.5
over protest................... minutes)
314.107(e)--notification of 247 2 494 0.5 (30 247
court actions or written minutes)
consent to approval............
----------------------------------------------------------------------------------------------------------------
Subparts G, H, and I
----------------------------------------------------------------------------------------------------------------
314.420--drug master files [FDA 36 27.2 981 61 59,841
3938]--original amendments.....
DMFs--technical, administrative, 2,946 11.4 33,590 8 268,720
REMS)..........................
DMFs--annual reports............ 2,946 3.33 9,834 4 39,336
314.550--Promotional material 55 11.6 640 120 76,800
and subpart H applications.....
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 4,118,933.5
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[[Page 9512]]
Our estimated burden for the information collection reflects a
decrease. We attribute this adjustment to improved operational
efficiencies with regard to Agency data systems and digital submission
processes.
Dated: February 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03023 Filed 2-12-21; 8:45 am]
BILLING CODE 4164-01-P
