Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Food and Drug Administration Approval To Market a New Drug, 73057-73060 [2020-25239]
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Federal Register / Vol. 85, No. 221 / Monday, November 16, 2020 / Notices
sensitive information is being collected
or used in furtherance of the research.
Historically, a CoC generally protected a
researcher from being compelled in a
legal proceeding (such as by subpoena
or court order) to disclose identifiable
and sensitive information about the
research participant, created or
compiled for purposes of the human
subject research. The Cures Act
broadened the protections of the
statutory provision by affirmatively
prohibiting holders of CoCs from
disclosing such information unless a
specific exception applies.
The Cures Act simplified certain
aspects of the issuance of CoCs by
requiring that CoCs be issued for
federally funded human subject
research that collects or uses
identifiable, sensitive information
(referred to in the guidance as
mandatory CoCs). For non-federally
funded research, issuance of CoCs is not
required but may be issued at the
discretion of FDA (referred to in the
guidance as discretionary CoCs) when
the study involves a product subject to
FDA’s jurisdiction and regulatory
authority. FDA intends to continue
receiving such requests and will issue
discretionary CoCs as appropriate. This
guidance is intended to provide
information on how to request a
discretionary CoC, the statutory
requirements for requesting such a CoC,
and the statutory responsibilities
associated with possessing a CoC.
Although the mandatory CoC and the
discretionary CoC are issued under
different processes, the protections
afforded by the issuance of either CoC
are identical and the statutory
responsibilities are applicable to both.
This guidance finalizes the draft
guidance entitled ‘‘Certificates of
Confidentiality; Guidance for Sponsors,
Sponsor-Investigators, Researchers,
Industry, and Food and Drug
Administration Staff’’ issued on
November 25, 2019 (84 FR 64906). FDA
considered comments received on the
draft guidance as the guidance was
finalized. Changes from the draft to the
final guidance were made to address
requests for definitional and process
clarity.
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 ‘‘Certificates of
Confidentiality; Guidance for Sponsors,
Sponsor-Investigators, Researchers,
Industry, and Food and Drug
Administration Staff.’’ 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
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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
a previously approved FDA collection 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. The previously
approved collections of information are
subject to review by OMB under the
PRA. The collections of information
have been approved under OMB control
number 0910–0130.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: November 9, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–25238 Filed 11–13–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2030]
Agency Information Collection
Activities; Proposed Collection;
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 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 information
collection associated with applications
for FDA approval to market a new drug.
DATES: Submit either electronic or
written comments on the collection of
information by January 15, 2021.
SUMMARY:
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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 January 15,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 15, 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.
ADDRESSES:
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–N–2030 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Application for FDA Approval To
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Federal Register / Vol. 85, No. 221 / Monday, November 16, 2020 / Notices
Market a New Drug.’’ 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
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.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
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(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.
Application for FDA Approval To
Market a New Drug;
OMB Control No. 0910–0001—Revision
This information collection supports
FDA regulations. Under § 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
§ 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 (§§ 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
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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
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.
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Included among the miscellaneous
provisions in subpart G (§§ 314.410–
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.
73059
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
www.fda.gov/drugs/drug-approvalsand-databases/approved-drug-productstherapeutic-equivalence-evaluationsorange-book.
We estimate the burden for this
collection of information 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
15
2.875
2.084
1
3
808
646
17
45
10 ........................
15 ........................
2 ..........................
15 ........................
8,080
9,690
34
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
1
6
2 ..........................
12
14
492
1.21
6.57
17
3,232
2 ..........................
150 ......................
34
484,800
67
484
1.45
20.3
97
9,834
2 ..........................
8 ..........................
194
78,672
626
331
4.9
141.3
3,066
46,782
40 ........................
2 ..........................
122,640
93,564
229
153
4.3
1
987
153
480 ......................
2 ..........................
473,760
306
400
451
1
3
36.2
1
1,200
16,311
1
0.33 (20 minutes)
80 ........................
300 ......................
400
1,304,880
300
100
361
1
1
22.8
1
100
8,237
1
2 ..........................
80 ........................
300 ......................
200
658,960
300
77
2.3
177
2 ..........................
354
135
1.24
167
2 ..........................
334
1
1
0.5 (30 minutes) ..
0.5
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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) ........
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 ......................
SUBPART D
314.101(a)—NDA or ANDA filing over protest ..............
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Federal Register / Vol. 85, No. 221 / Monday, November 16, 2020 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—Continued
Number of
respondents
21 CFR section
314.107(e)—notification of court actions or written consent to approval.
Number of
responses per
respondent
247
Average burden
per response
(in hours)
Total annual
responses
Total hours
2
494
0.5 (30 minutes) ..
247
36
27.2
981
61 ........................
59,841
2,946
2,946
55
11.4
3.33
11.6
33,590
9,834
640
8 ..........................
4 ..........................
120 ......................
268,720
39,336
76,800
........................
........................
........................
.............................
4,118,933.5
SUBPART G, H, 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.
Total ........................................................................
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: November 10, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–25239 Filed 11–13–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: Coronavirus 2019
(COVID–19) Data Report OMB No.
0906–0053—Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
ACTION:
Notice.
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30 day
comment period for this notice has
closed.
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SUMMARY:
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Comments on this ICR should be
received no later than December 16,
2020.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to 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.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Coronavirus 2019 Data Report OMB No.
0906–0053—Extension.
Abstract: HRSA’s Ryan White HIV/
AIDS Program (RWHAP) funds and
coordinates with cities, states, and local
clinics/community-based organizations
to deliver efficient and effective HIV
care, treatment, and support to low
income people with HIV. Nearly twothirds of clients (patients) live at or
below 100 percent of the federal poverty
level and approximately three-quarters
of RWHAP clients are racial/ethnic
minorities. Since 1990, the RWHAP has
developed a comprehensive system of
safety net providers who deliver high
quality direct health care and support
services to over half a million people
with HIV—more than 50 percent of all
people with diagnosed HIV in the
United States.
DATES:
FY 2020 Coronavirus Aid, Relief, and
Economic Security (CARES) Act
On March 27, 2020, the President
signed into law the ‘‘Coronavirus Aid,
Relief, and Economic Security Act’’
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(CARES Act). The CARES Act
appropriated $90 million to HRSA’s
RWHAP to prevent, prepare for, and
respond to coronavirus disease 2019
(COVID–19). This funding supports 581
RWHAP Parts A, B, C, D and F
recipients across the country, including
city/county health departments, state
health departments, health clinics,
community-based organizations, and
AIDS Education and Training Centers in
their efforts to help prevent or minimize
the impact of COVID–19 on RWHAP
clients. The award provides RWHAP
recipients the flexibility to meet
evolving COVID–19 needs in their
respective communities, including
extending operational hours, increasing
staffing hours, purchasing additional
equipment, enhancing workforce
training and capacity development, and
providing critical services to people
with HIV during this pandemic, such as
home-delivered meals, emergency
housing, and transportation.
HRSA’s HIV/AIDS Bureau identified a
new data collection need to support
HRSA’s requirement to monitor and
report quarterly to the Secretary of HHS
the COVID–19 activities conducted with
the CARES Act funding. The COVID–19
Data Report (CDR) module will collect
information on the types of services
provided and number of people served
for the treatment or prevention of
COVID–19 among RWHAP clients (and
immediate household members in
limited circumstances). This module
will be required for all providers (e.g.,
recipients or subrecipients) who receive
CARES Act RWHAP funding.
A 60-day notice published in the
Federal Register on September 1, 2020,
vol. 85, No. 170; pp. 54390–54391.
There were no public comments.
Need and Proposed Use of the
Information: HRSA proposes that
service providers who receive CARES
Act RWHAP funding report aggregate
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]]>Agencies
[Federal Register Volume 85, Number 221 (Monday, November 16, 2020)]
[Notices]
[Pages 73057-73060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25239]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2030]
Agency Information Collection Activities; Proposed Collection;
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 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 information collection associated with
applications for FDA approval to market a new drug.
DATES: Submit either electronic or written comments on the collection
of information by January 15, 2021.
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 January 15, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 15, 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.
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-N-2030 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Application for FDA Approval To
[[Page 73058]]
Market a New Drug.'' 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 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.
Application for FDA Approval To Market a New Drug;
OMB Control No. 0910-0001--Revision
This information collection supports FDA regulations. Under Sec.
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
Sec. 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.
[[Page 73059]]
Included among the miscellaneous provisions in subpart G
(Sec. Sec. 314.410-314.445), 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
www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book.
We estimate the burden for this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden per response (in hours) Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
SUBPART B
--------------------------------------------------------------------------------------------------------------------------------------------------------
314.50(a)-(l)--Content and format of a 121 1.15 139 1,921................................... 267,019
505(b)(1) or 505(b)(2) application.
314.50(i)(1)--patent certifications Form FDA 281 2.875 808 10...................................... 8,080
3542.
Form FDA 3542a................................ 310 2.084 646 15...................................... 9,690
314.50(i)(6) amended patent certifications.... 17 1 17 2....................................... 34
314.52(a), (b), and (e)--NDAs--notice of 15 3 45 15...................................... 675
noninfringement of patent certification.
314.52(c)--Noninfringement of patent 22 3 66 0.33 (20 minutes)....................... 22
certification notice content.
314.53(f)(1)--Correction of patent information 24 1 24 10...................................... 240
errors by persons other than the NDA holder.
314.53(f)(2)--Correction of patent information 28 1.4 39 1....................................... 39
errors by the NDA holder.
314.60--Amendments to unapproved NDA, 256 8.23 2,106 80...................................... 168,480
supplement or resubmission.
314.60(f)--patent certifications for 6 1 6 2....................................... 12
unapproved applications.
314.65--Withdrawal of unapproved applications. 14 1.21 17 2....................................... 34
314.70 and 314.71--Supplements and other 492 6.57 3,232 150..................................... 484,800
changes to approved application.
314.72--Changes of ownership of NDAs.......... 67 1.45 97 2....................................... 194
314.81--Other postmarketing reports 484 20.3 9,834 8....................................... 78,672
314.81(b)(1) [3331 and 3331a field alert
reports and followups].
314.81(b)(2)[2252]--Annual reports............ 626 4.9 3,066 40...................................... 122,640
314.81(b)(2)[2253]--Promotional labeling...... 331 141.3 46,782 2....................................... 93,564
--------------------------------------------------------------------------------------------------------------------------------------------------------
SUBPART C
--------------------------------------------------------------------------------------------------------------------------------------------------------
314.94(a)and(d)--ANDA content................. 229 4.3 987 480..................................... 473,760
314.94(a)(12)(viii) amended patent 153 1 153 2....................................... 306
certifications before approval of ANDA.
314.95(c)--Non-infringement of patents (ANDAs) 400 3 1,200 0.33 (20 minutes)....................... 400
314.96(a)(1)--Amendments to unapproved ANDAs.. 451 36.2 16,311 80...................................... 1,304,880
314.96(c) amendment for pharmaceutical 1 1 1 300..................................... 300
equivalent to a listed drug other than RLD.
314.96(d)--patent certification requirements.. 100 1 100 2....................................... 200
314.97--Supplements and other changes to ANDAs 361 22.8 8,237 80...................................... 658,960
314.97(b) Supplements to ANDA for 1 1 1 300..................................... 300
pharmaceutical equivalent to a listed drug
other than RLD.
314.99(a)--ANDA Applicants: Withdrawal of 77 2.3 177 2....................................... 354
unapproved ANDAs.
314.99(a)--ANDA Transfer of ownership......... 135 1.24 167 2....................................... 334
--------------------------------------------------------------------------------------------------------------------------------------------------------
SUBPART D
--------------------------------------------------------------------------------------------------------------------------------------------------------
314.101(a)--NDA or ANDA filing over protest... 1 1 1 0.5 (30 minutes)........................ 0.5
[[Page 73060]]
314.107(e)--notification of court actions or 247 2 494 0.5 (30 minutes)........................ 247
written consent to approval.
--------------------------------------------------------------------------------------------------------------------------------------------------------
SUBPART G, H, I
--------------------------------------------------------------------------------------------------------------------------------------------------------
314.420--drug master files [FDA 3938]-- 36 27.2 981 61...................................... 59,841
original amendments.
DMFs--technical, administrative, REMS)........ 2,946 11.4 33,590 8....................................... 268,720
DMFs--annual reports.......................... 2,946 3.33 9,834 4....................................... 39,336
314.550--Promotional material and subpart H 55 11.6 640 120..................................... 76,800
applications.
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Total..................................... .............. .............. .............. ........................................ 4,118,933.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
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: November 10, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25239 Filed 11-13-20; 8:45 am]
BILLING CODE 4164-01-P
