[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]


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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.

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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, 
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 
(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 formsmanager@OC.FDA.GOV. 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
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                                                                   Number of
                21 CFR section                     Number of     responses per   Total annual   Average burden  per response  (in hours)    Total hours
                                                  respondents     respondent       responses
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                                                                        SUBPART B
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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
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                                                                        SUBPART C
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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
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                                                                        SUBPART D
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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.
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                                                                     SUBPART G, H, I
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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
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    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


