[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
----------------------------------------------------------------------------------------------------------------


[[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