Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational New Drug Application Regulations, 9058-9064 [2022-03432]
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Federal Register / Vol. 87, No. 33 / Thursday, February 17, 2022 / Notices
regulations in part 820 (21 CFR part
820), which govern the methods used
in, and the facilities and controls used
for, the design, manufacture, packaging,
labeling, storage, installation, and
servicing of all finished devices
intended for human use. Manufacturers
are required to maintain complaint files
and to review and evaluate complaints
for these devices under § 820.198 (21
CFR 820.198) (approved under OMB
control number 0910–0073).
Complaints required to be reported in
the annual logs under the proposed
special controls, such as certain
complaints involving unusually high
invalid rates or issues with users
conducting the test, may not meet the
definition of a medical device report
required to be reported to FDA under 21
CFR part 803 (Medical Device
Reporting; currently approved under
OMB control number 0910–0437), but
could potentially affect the safety and
effectiveness of these devices. The
submission of the complaint log would
provide us with earlier notification of
concerns and enable us to determine
whether they have been adequately
addressed. The Agency usually would
not evaluate this kind of complaint
information until an FDA inspection,
which typically occurs less frequently
than annually. We believe
implementing these specific reporting
measures as part of the special controls
would be necessary to provide a
reasonable assurance of safety and
effectiveness for HIV diagnostic and
supplemental tests subject to the
proposed order.
Finalizing the proposed order would
add classification regulations for these
devices in 21 CFR part 866
(Immunology and Microbiology
Devices) at 21 CFR 866.3956 for the HIV
serological diagnostic and supplemental
tests, and 21 CFR 866.3957 for the HIV
NAT diagnostic and supplemental tests,
and establish special controls necessary
to provide reasonable assurance of their
safety and effectiveness. As described
above, the special controls would
require the submission of a log of all
complaints annually for a period of 5
years following FDA clearance of a
traditional 510(k) submission for one of
these devices. We are requesting
approval to revise the scope of the
information collections included in
OMB control number 0910–0437
(medical device reporting) to include
the information collection associated
with this special control provision.
Description of Respondents: The
respondents to the information
collection are manufacturers of HIV
diagnostic and supplemental test
devices that would be subject to the
proposed order, if finalized.
In the Federal Register of June 25,
2021 (86 FR 33708), we published a 60day notice requesting public comment
on the new reporting provisions of the
proposed order. One comment was
received, however it was not responsive
to the four information collection topics
solicited, nor did it suggest FDA revise
its burden estimate.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section; activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Proposed 21 CFR 866.3956(b)(1)(iii) and
866.3957(b)(1)(iii), Submission of log to FDA .................
10
1
10
3
30
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of the average
burden per response on our experience
with other types of annual report
submissions. We base our estimate of
the number of affected respondents on
the expected number of manufacturers
that would be submitting a 510(k) for a
new device or changes to an existing
device that would require a 510(k).
As noted above, manufacturers of the
devices subject to the proposed order
must already maintain complaint files
and review and evaluate complaints
under § 820.198. If the proposed order is
finalized as proposed, we estimate it
would take a manufacturer
approximately 3 hours annually to
review their existing records, prepare
the complaint log, and submit it to FDA.
Although respondents may submit the
information electronically through the
FDA Electronic Submission Gateway, on
paper, or electronic media (e.g., CD,
DVD) to the Center for Biologics
Evaluation and Research’s Document
Control Center, we assume that all
manufacturers will submit their logs
electronically.
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Dated: February 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–03437 Filed 2–16–22; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket No. FDA–2014–N–1721]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Investigational
New Drug Application Regulations
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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.
SUMMARY:
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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 0910–0014. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Submit written comments
(including recommendations) on the
collection of information by March 21,
2022.
DATES:
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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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
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collection of information to OMB for
review and clearance.
Investigational New Drug Application
Regulations—21 CFR part 312
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OMB Control Number 0910–0014—
Revision
This information collection supports
implementation of provisions of section
505 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355) and of the licensing provisions of
the Public Health Service Act (42 U.S.C.
201 et seq.) that govern investigational
new drugs and investigational new drug
applications (INDs). Implementing
regulations are found in part 312 (21
CFR part 312), and provide for the
issuance of guidance documents (see
§ 312.145 (21 CFR 312.145)) to assist
persons in complying with the
applicable requirements. The
information collection applies to all
clinical investigations subject to section
505 of the FD&C Act and include the
following types of INDs:
• An Investigator IND is submitted by
a physician who both initiates and
investigates, and under whose
immediate direction the investigational
drug is administered or dispensed. A
physician might submit a research IND
to propose studying an unapproved
drug or an approved product for a new
indication or in a new patient
population.
• Emergency Use IND allows FDA to
authorize use of an experimental drug in
an emergency situation that does not
allow time for submission of an IND in
accordance with § 312.23 or § 312.20 (21
CFR 312.23 or 312.20). It is also used for
patients who do not meet the criteria of
an existing study protocol or if an
approved study protocol does not exist.
• Treatment IND is submitted for
experimental drugs showing promise in
clinical testing for serious or
immediately life-threatening conditions
while the final clinical work is
conducted and FDA’s review takes
place.
There are two IND categories:
Commercial and research (noncommercial).
General IND requirements include
submitting an initial application as well
as amendments to that application;
submitting reports on significant
revisions of clinical investigation plans;
submitting information to the clinical
trials data bank (https://
clinicaltrials.gov) established by the
National Institutes of Health/National
Library of Medicine, including
expanded information on certain
clinical trials and information on the
results of these clinical trials; and
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reporting information on a drug’s safety
or effectiveness. In addition, sponsors
are required to provide to FDA an
annual summary of the previous year’s
clinical experience. The regulations also
include recordkeeping requirements
regarding the disposition of drugs,
records regarding individual case
histories, and certain other
documentation verifying clinical
investigators’ fulfillment of
responsibilities.
Form FDA 1571 entitled
‘‘Investigational New Drug Application
(IND)’’ and Form FDA 1572 entitled
‘‘Statement of Investigator,’’ were
developed to assist respondents with
the information collection and provide
for uniform reporting of required data
elements. The information is required to
be submitted electronically. Individuals
who are interested in receiving printed
forms may send an email request to the
FDA Forms Manager at formsmanager@
OC.FDA.GOV. Fees may apply.
Sponsors (including sponsorinvestigators) interested in filing or
updating a research IND may use a new
web-based interface developed for use
by mobile device or desktop to help in
completing Form FDA 1571. The webbased interface also allows respondents
to electronically submit completed
Form FDA 1571 and associated files. For
more information regarding Forms FDA
1571 and 1572 visit https://
www.fda.gov/news-events/expandedaccess/how-complete-form-fda-1571and-form-fda-1572.
Human drug, biological product, and
device product submissions must be
accompanied by Form FDA 3674, as
discussed in the guidance document
entitled ‘‘Form FDA 3674—
Certifications To Accompany Drug,
Biological Product, and Device
Applications/Submissions’’ (updated
November 2017), available from our
website at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/form-fda-3674certifications-accompany-drugbiological-product-and-deviceapplicationssubmissions. The guidance
document provides procedural
instruction on completing and
submitting required information to FDA.
As communicated in the instructions,
the certification must accompany the
application or submission and be
included at the time of submission to
FDA.
Regulations in part 312, subpart B,
specify content and format requirements
for applications, amendments, annual
reporting, and withdrawals, including
content and format requirements for
protocol and information amendments.
The regulations also explain phases of
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an investigation and set forth principles
of IND submissions.
Regulations in part 312, subpart C,
describe administrative actions
pertaining to respondents’ requests for
and responses to clinical holds,
terminations, and inactive IND status
determinations, as well as various types
of meetings (for example, End-of-Phase
2 and Pre-new drug application (NDA)
meetings).
Regulations in part 312, subpart D, set
forth sponsor and investigator
responsibilities, including general
responsibilities; transfer of obligations
to a contract research organization;
recordkeeping and record retention
controls; reporting responsibilities; and
responsibility for disposition of unused
supply of investigational drug. The
regulations also provide for investigator
controls including review of ongoing
investigations; compliance with
requirements regarding the protection of
human subjects and institutional review
board assurance; and disqualification of
clinical investigators.
Regulations in part 312, subpart E,
sets forth requirements applicable to
drugs intended to treat life-threatening
and severely debilitating illnesses. The
regulations establish procedures to
reflect that physicians and patients
accept greater risk or side effects from
products that treat life-threatening and
severely debilitating illnesses than they
would accept from products that treat
less serious illnesses. The procedures
also reflect the recognition that the
benefits of the drug need to be evaluated
in light of the severity of the disease
being treated.
Regulations in part 312, subpart F,
include provisions pertaining to import
and export requirements; foreign
clinical studies not conducted under an
IND; the disclosure of data and
information in an IND; and the issuance
of guidance documents. We are revising
the information collection to account for
burden that may be associated with
recommendations found in Agency
guidance documents.
• The guidance document entitled
‘‘Oversight of Clinical Investigations’’
(August 2013) communicates risk-based
monitoring strategies and recommends
plans for investigational studies of
medical products, including human
drug and biological products, medical
devices, and combinations thereof. The
guidance document is intended to
enhance human subject protection and
the quality of clinical trial data by
focusing sponsor oversight on the most
important aspects of study conduct and
reporting. The guidance also
communicates that sponsors can use a
variety of approaches to fulfill
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responsibilities for monitoring clinical
investigator conduct and performance in
IND studies, and provides a description
of strategies for monitoring activities to
reflect a modern, risk-based approach.
The guidance document recommends
that respondents develop a written
comprehensive monitoring plan and
describes monitoring approaches for
respondents to consider (Guidance
Section IV.D.).
• The guidance document entitled
‘‘Pharmacogenomic Data Submissions’’
(March 2005) provides
recommendations intended to assist
sponsors submitting or holding INDs,
NDAs, or biologics license applications
(BLAs) with submission requirements
for relevant data regarding drug safety
and effectiveness (including §§ 312.22,
312.23, 312.31, 312.33, 314.50, 314.81,
601.2, and 601.12 (21 CFR 312.22,
312.23, 312.31, 312.33, 314.50, 314.81,
601.2 and 601.12)). Because the
regulations were developed before the
advent of widespread animal or human
genetic or gene expression testing, the
regulations do not specifically address
when such data must be submitted. The
guidance document includes content
and format recommendations regarding
pharmacogenomic data submissions.
Although we have not received any
pharmacogenomic submissions since
2013, we assume an average of 50 hours
for preparing and providing information
to FDA as recommended in the
guidance and estimate one submission
annually.
• The guidance document entitled
‘‘Adaptive Designs for Clinical Trials of
Drugs and Biologics’’ (December 2019)
was developed to assist sponsors and
applicants submitting INDs, NDAs,
BLAs, or supplemental applications on
the appropriate use of adaptive designs
for clinical trials to provide evidence of
the effectiveness and safety of a drug or
biologic. The guidance document
describes important principles for
designing, conducting, and reporting the
results from an adaptive clinical trial,
and advises sponsors on the types of
information to submit to facilitate FDA
evaluation of clinical trials with
adaptive designs, including Bayesian
adaptive and complex trials that rely on
computer simulations for their design.
The guidance document also helps to
fulfill FDA Commitment Goals under
the Prescription Drug User Fee Act
pertaining to the enhancement of
regulatory decision tools.
The referenced guidance documents
are available for download from our
website at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents and were issued
consistent with § 312.145 to help
respondents comply with requirements
in part 312. In publishing the respective
notices of availability for each guidance
document, we included an analysis
under the PRA and invited public
comment on the associated information
collection recommendations. In
addition, all Agency guidance
documents are issued in accordance
with our Good Guidance Practice
regulations in 21 CFR 10.115, which
provide for public comment at any time.
Regulations in part 312, subpart G,
provide for drugs for investigational use
in laboratory research animals or in
vitro tests.
In the Federal Register of November
24, 2021 (86 FR 67060), we published a
60-day notice requesting public
comment on the proposed collection of
information. Although we received two
general comments, neither discussed the
four information collection topics
solicited in our 60-day notice or
suggested that we revise our burden
estimate.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS 1
Number of
respondents
21 CFR section; activity
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total
hours
Subpart A—General Provisions: §§ 312.1 through 312.10
§ 312.2(e); requests for FDA advice on the applicability of
part 312 to a planned clinical investigation ......................
§ 312.8; requests to charge for an investigational drug ......
§ 312.10; waiver requests ....................................................
454
14
5
1.528
1.64
1
694
23
5
24
48
24
16,656
1,104
120
Subtotal Subpart A Center for Biologics Evaluation
and Research (CBER) ..............................................
........................
........................
722
........................
17,880
Subpart B—Investigational New Drug Application (IND): §§ 312.20 through 312.38 (Including Forms FDA 1571, 1572, and 3674)
§ 312.23(a) through (f); IND content and format .................
§ 312.30(a) through (e); protocol amendments ...................
§ 312.31(b); information amendments .................................
§ 312.32(c) and (d); IND safety reports ...............................
§ 312.33(a) through (f); IND annual reports ........................
§ 312.38(b) and (c); notifications of withdrawal of an IND ..
2,075
1,781
169
224
971
712
3.382
4.6692
2.48
10.59
2.2739
3.057
7,018
8,316
419
2,372
2,208
2,177
300
284
100
32
360
28
2,105,400
2,361,744
41,900
75,904
794,880
60,956
Subtotal Subpart B CBER ............................................
........................
........................
22,510
........................
5,440,784
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Subpart C—Administrative Actions: §§ 312.40 through 312.48
§ 312.42; clinical holds and requests for modification .........
§ 312.44(c) and (d); sponsor responses to FDA when IND
is terminated .....................................................................
§ 312.45(a) and (b); sponsor requests for or responses to
an inactive status determination of an IND by FDA ........
§ 312.47; meetings, including ‘‘End-of-Phase 2’’ meetings
and ‘‘Pre-NDA’’ meetings .................................................
154
1.65
254
284
72,136
86
1.22
105
16
1,680
48
1.48
71
12
852
157
1.80
283
160
45,280
Subtotal Subpart C CBER ............................................
........................
........................
713
........................
119,948
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS 1—Continued
Number of
responses per
respondent
Number of
respondents
21 CFR section; activity
Total
annual
responses
Average
burden per
response
Total
hours
Subpart D—Responsibilities of Sponsors and Investigators: §§ 312.50 through 312.70
§ 312.53(c); investigator reports submitted to the sponsor,
including Form FDA 1572, curriculum vitae, clinical protocol, and financial disclosure ..........................................
§ 312.54(a); sponsor submissions to FDA concerning investigations involving an exception from informed consent under § 50.24 ............................................................
§ 312.54(b); sponsor notifications to FDA and others concerning an institutional review board determination that
it cannot approve research because it does not meet
the criteria in the exception from informed consent in
§ 50.24(a) ..........................................................................
§ 312.55(a); number of investigator brochures submitted
by the sponsor to each investigator .................................
§ 312.55(b); number of sponsor reports to investigators on
new observations, especially adverse reactions and safe
use ....................................................................................
§ 312.56(b), (c), and (d); review of ongoing investigations
and associated notifications; sponsor notifications ..........
§ 312.58; inspection of records and reports by FDA ...........
§ 312.64; number of investigator reports to the sponsor, including progress reports, safety reports, final reports,
and financial disclosure reports .......................................
§ 312.70; disqualification of a clinical investigator by FDA
Subtotal Subpart D CBER ............................................
1,068
5.23
5,586
80
446,880
4
4.25
17
48
816
1
1
1
48
48
473
2.224
1,052
48
50,496
243
4.95
1,203
48
57,744
915
7
2.948
1
2,698
7
80
8
215,840
56
2,728
5
3.816
1
10,411
5
24
40
249,864
200
........................
........................
20,980
........................
1,021,944
Subpart F—Miscellaneous: §§ 312.110 through 312.145
§ 312.110(b)(4) and (b)(5); number of written certifications
and written statements submitted to FDA relating to the
export of an investigational drug ......................................
§ 312.120(b); number of submissions to FDA of ‘‘supporting information’’ related to the use of foreign clinical
studies not conducted under an IND ...............................
§ 312.120(c); number of waiver requests submitted to FDA
related to the use of foreign clinical studies not conducted under an IND ........................................................
§ 312.130; number of requests for disclosable information
in an IND and for investigations involving an exception
from informed consent under § 50.24 ..............................
18
1
18
75
1,350
280
9.82
2,750
32
88,000
7
2.29
16
24
384
350
1.342
470
8
3,760
Subtotal Subpart F CBER ............................................
........................
........................
3,254
........................
93,494
Total .......................................................................
........................
........................
48,179
........................
6,694,050
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS 1
Number of
recordkeepers
21 CFR section; activity
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total
hours
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Subpart D—Responsibilities of Sponsors and Investigators: §§ 312.50 through 312.70
§ 312.52(a); sponsor records for the transfer of
obligations to a contract research organization.
§ 312.57; sponsor recordkeeping showing the
receipt, shipment, or other disposition of the
investigational drug, and any financial interest.
§ 312.62(a); investigator recordkeeping of the
disposition of drugs.
§ 312.62(b); investigator recordkeeping of case
histories of individuals.
Subtotal Subpart D CBER ...........................
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94
2.26
212
2 ......................................
424
335
2.70
904
100 ..................................
90,400
453
1
453
40 ....................................
18,120
453
1
453
40 ....................................
18,120
........................
........................
2,022
.........................................
127,064
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TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS 1—Continued
Number of
recordkeepers
21 CFR section; activity
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total
hours
Subpart G—Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests
§ 312.160(a)(3); records pertaining to the shipment of drugs for investigational use in laboratory research animals or in vitro tests.
§ 312.160(c) shipper records of alternative disposition of unused drugs.
111
1.40
155
0.5 (30 minutes) .............
78
111
1.40
155
0.5 (30 minutes) .............
78
Subtotal Subpart G CBER ...........................
........................
........................
310
.........................................
156
Total ......................................................
........................
........................
2,332
.........................................
127,220
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1
Number of
responses per
respondent
Number of
respondents
21 CFR section; activity
Average
burden per
response
Total annual
responses
Total hours
Subpart A—General Provisions
§ 312.2(e); requests for FDA advice on the applicability of
part 312 to a planned clinical investigation ......................
§ 312.8; requests to charge for an investigational drug ......
§ 312.10; requests to waive a requirement in part 312 .......
419
25
68
1
1.28
1.5
419
32
102
24
48
24
10,056
1,536
2,448
Subtotal Subpart A Center for Drug Evaluation and
Research (CDER) .....................................................
........................
........................
553
........................
14,040
Subpart B—Investigational New Drug Application (IND)
§ 312.23(a) through (f); IND content and format (including
Forms FDA 1571 and 3674) ............................................
§ 312.30(a) through (e); protocol amendments ...................
§ 312.31(b); information amendments .................................
§ 312.32(c) and (d); IND safety reports ...............................
§ 312.33(a) through (f); IND annual reports ........................
§ 312.38(b) and (c); notifications of withdrawal of an IND ..
4,886
11,847
8,094
892
3,777
1,549
1.4662
3.2367
3.30899
15.848
2.9097
1.834
7,164
38,346
26,783
14,137
10,990
2,841
300
284.25
100
32
360
28
2,149,200
10,899,850
2,678,300
452,384
3,956,400
79,548
Subtotal Subpart B CDER ............................................
........................
........................
100,261
........................
20,215,682
Subpart C—Administrative Actions: §§ 312.40 through 312.48
§ 312.42; clinical holds and requests for modifications .......
§ 312.44(c) and (d); sponsor responses to FDA when IND
is terminated .....................................................................
§ 312.45(a) and (b); sponsor requests for or responses to
an inactive status determination of an IND by FDA ........
§ 312.47; meetings, including ‘‘End-of-Phase 2’’ meetings
and ‘‘Pre-NDA’’ meetings .................................................
Subtotal Subpart C CDER ............................................
181
1.28
232
284
65,888
1
1
1
16
16
213
1.72
367
12
4,404
174
2.885
502
160
80,320
........................
........................
1,102
........................
150,628
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Subpart D—Responsibilities of Sponsors and Investigators
§ 312.54(a); sponsor submissions to FDA concerning investigations involving an exception from informed consent under § 50.24 ............................................................
§ 312.54(b); sponsor notifications to FDA and others concerning an institutional review board determination that
it cannot approve research because it does not meet
the criteria in the exception from informed consent in
§ 50.24(a) ..........................................................................
§ 312.56; review of ongoing investigations and associated
notifications .......................................................................
§ 312.58; inspection of records and reports by FDA ...........
§ 312.70; disqualification of a clinical investigator by FDA.
Subtotal Subpart D CDER ............................................
VerDate Sep<11>2014
17:23 Feb 16, 2022
Jkt 256001
PO 00000
7
1.14
8
48
384
2
1
2
48
96
4,570
73
5
5.4689
1
1
24,993
73
5
80
8
40
1,999,440
584
200
........................
........................
25,081
........................
2,000,704
Frm 00036
Fmt 4703
Sfmt 4703
E:\FR\FM\17FEN1.SGM
17FEN1
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Federal Register / Vol. 87, No. 33 / Thursday, February 17, 2022 / Notices
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1—Continued
Number of
responses per
respondent
Number of
respondents
21 CFR section; activity
Average
burden per
response
Total annual
responses
Total hours
Subpart F—Miscellaneous: §§ 312.110 through 312.145
§ 312.110(b)(4) and (b)(5); written certifications and written
statements submitted to FDA relating to the export of an
investigational drug ..........................................................
§ 312.120(b); submissions to FDA of ‘‘supporting information’’ related to the use of foreign clinical studies not
conducted under an IND ..................................................
§ 312.120(c); waiver requests submitted to FDA related to
the use of foreign clinical studies not conducted under
an IND ..............................................................................
§ 312.130; requests for disclosable information in an IND
and for investigations involving an exception from informed consent under § 50.24 .........................................
§ 312.145; Guidance Documents:
Oversight of Clinical Investigations (2013) ...................
Pharmacogenomic Data Submissions (2005) ..............
Adaptive Designs for Clinical Trials of Drugs and Biologics (2019) ..............................................................
8
22.375
179
75
13,425
1,964
7.352
14,440
32
462,080
68
1.5
102
24
2,448
3
1
3
8
24
88
1
1.5
1
132
1
4
50
528
50
55
4.727
260
50
13,000
Subtotal Subpart F CDER .........................................
........................
........................
15,117
........................
491,555
Total .......................................................................
........................
........................
142,114
........................
22,872,609
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR HUMAN DRUGS 1
Number of
recordkeepers
21 CFR section; activity
Number of
records per
recordkeeper
Total annual
records
Average burden per
recordkeeping
Total hours
Subpart D—Responsibilities of Sponsors and Investigators
§ 312.52(a); transfer of obligations to a contract
research organization.
§ 312.57; records showing the receipt, shipment, or other disposition of the investigational drug and any financial interests.
§ 312.62(a); records on disposition of drugs ......
§ 312.62(b); records on case histories of individuals.
Subtotal Subpart D CDER ...........................
466
3.107
1,448
300 ..................................
434,400
13,000
1
13,000
100 ..................................
1,300,000
13,000
2,192
1
6.587
13,000
14,439
40 ....................................
40 ....................................
520,000
577,560
........................
........................
41,887
.........................................
2,831,960
Subpart G—Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests
§ 312.160(a)(3); records pertaining to the shipment of drugs for investigational use in laboratory research animals or in vitro tests.
§ 312.160(c); shipper records of alternative disposition of unused drugs.
547
1.43
782
0.50 (30 minutes) ...........
391
547
1.43
782
0.50 (30 minutes) ...........
391
Subtotal ....................................................
........................
........................
1,564
.........................................
782
Total ......................................................
........................
........................
43,451
.........................................
2,832,742
lotter on DSK11XQN23PROD with NOTICES1
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The information collection reflects
program changes and adjustments. We
have revised the information collection
to account for burden that may be
incurred by respondents who choose to
adopt or implement recommendations
discussed in referenced Agency
guidance documents intended to assist
respondents in complying with
VerDate Sep<11>2014
17:23 Feb 16, 2022
Jkt 256001
regulatory requirements in part 312. We
have also made adjustments to
individual collection elements,
specifically with regard to protocol
amendments and emergency INDs for
both human drugs and biological drugs.
We attribute the increase for these
elements to a corresponding increase in
submissions since last OMB review and
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
approval of the information collection
and the ongoing public health
emergency. Finally, we have removed
burden we attribute to provisions in part
312, subpart I: Expanded Access to
Investigational Drugs for Treatment Use
and are revising OMB control number
0910–0814 to include burden associated
with information collection applicable
E:\FR\FM\17FEN1.SGM
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Federal Register / Vol. 87, No. 33 / Thursday, February 17, 2022 / Notices
to these regulatory provisions for
efficiency of Agency operations. As a
result of these cumulative changes and
adjustments, the information collection
reflects an overall decrease in both
annual responses and burden hours.
Dated: February 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–03432 Filed 2–16–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0895]
Issuance of Priority Review Voucher;
Material Threat Medical
Countermeasure Product
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a material threat medical
countermeasure (MCM) product
application. The Federal Food, Drug,
and Cosmetic Act (FD&C Act), as
amended by the 21st Century Cures Act
(Cures Act), authorizes FDA to award
priority review vouchers to sponsors of
approved material threat MCM product
applications that meet certain criteria.
FDA is required to publish notice of the
award of the priority review voucher.
COMIRNATY (COVID–19 Vaccine,
mRNA) was approved on August 23,
2020, and a license was issued to
BioNTech Manufacturing GmbH. FDA
has determined that COMIRNATY
(COVID–19 Vaccine, mRNA) meets the
criteria for a material threat MCM
priority review voucher, which has been
issued to BioNTech Manufacturing
GmbH.
FOR FURTHER INFORMATION CONTACT:
Myrna Hanna, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a material
threat MCM priority review voucher to
the sponsor of an approved material
threat MCM product application. Under
section 565A of the FD&C Act (21 U.S.C.
360bbb–4a), which was added by the
Cures Act (Pub. L. 114–255), FDA will
award priority review vouchers to
sponsors of approved material threat
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:23 Feb 16, 2022
Jkt 256001
MCM product applications that meet
certain criteria upon approval of those
applications. FDA has determined that
COMIRNATY (COVID–19 Vaccine,
mRNA) meets the criteria for a material
threat MCM priority review voucher,
which has been issued to BioNTech
Manufacturing GmbH. COMIRNATY is
indicated for active immunization to
prevent coronavirus disease 2019
(COVID–19) caused by severe acute
respiratory syndrome coronavirus 2
(SARS–CoV–2) in individuals 16 years
of age and older.
For further information about the
material threat MCM Priority Review
Voucher Program and for a link to the
full text of section 565A of the FD&C
Act, go to https://www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policyframework/mcm-relatedcounterterrorism-legislation. For further
information about COMIRNATY
(COVID–19 Vaccine, mRNA) go to the
Center for Biologics Evaluation and
Research Approved Vaccine Products
website at https://www.fda.gov/
vaccines-blood-biologics/vaccines/
approved-vaccine-products.
Dated: February 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–03426 Filed 2–16–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0410]
Peripheral and Central Nervous
System Drugs 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 Peripheral and Central
Nervous System Drugs Advisory
Committee. The general function of the
committee 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 take place
virtually on March 30, 2022, from 10
a.m. to 4:30 p.m. Eastern Time.
SUMMARY:
PO 00000
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Fmt 4703
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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–2018–N–0410.
The docket will close on March 29,
2022. Submit either electronic or
written comments on this public
meeting by March 29, 2022. Please note
that late, untimely filed comments will
not be considered. Electronic comments
must be submitted on or before March
29, 2022. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
March 29, 2022. 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 16, 2022, will be provided to the
committee. 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:
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.
E:\FR\FM\17FEN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 33 (Thursday, February 17, 2022)]
[Notices]
[Pages 9058-9064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03432]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1721]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Investigational New
Drug Application Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 21, 2022.
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 0910-0014. 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
[[Page 9059]]
collection of information to OMB for review and clearance.
Investigational New Drug Application Regulations--21 CFR part 312
OMB Control Number 0910-0014--Revision
This information collection supports implementation of provisions
of section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 355) and of the licensing provisions of the Public Health
Service Act (42 U.S.C. 201 et seq.) that govern investigational new
drugs and investigational new drug applications (INDs). Implementing
regulations are found in part 312 (21 CFR part 312), and provide for
the issuance of guidance documents (see Sec. 312.145 (21 CFR 312.145))
to assist persons in complying with the applicable requirements. The
information collection applies to all clinical investigations subject
to section 505 of the FD&C Act and include the following types of INDs:
An Investigator IND is submitted by a physician who both
initiates and investigates, and under whose immediate direction the
investigational drug is administered or dispensed. A physician might
submit a research IND to propose studying an unapproved drug or an
approved product for a new indication or in a new patient population.
Emergency Use IND allows FDA to authorize use of an
experimental drug in an emergency situation that does not allow time
for submission of an IND in accordance with Sec. 312.23 or Sec.
312.20 (21 CFR 312.23 or 312.20). It is also used for patients who do
not meet the criteria of an existing study protocol or if an approved
study protocol does not exist.
Treatment IND is submitted for experimental drugs showing
promise in clinical testing for serious or immediately life-threatening
conditions while the final clinical work is conducted and FDA's review
takes place.
There are two IND categories: Commercial and research (non-
commercial).
General IND requirements include submitting an initial application
as well as amendments to that application; submitting reports on
significant revisions of clinical investigation plans; submitting
information to the clinical trials data bank (https://clinicaltrials.gov) established by the National Institutes of Health/
National Library of Medicine, including expanded information on certain
clinical trials and information on the results of these clinical
trials; and reporting information on a drug's safety or effectiveness.
In addition, sponsors are required to provide to FDA an annual summary
of the previous year's clinical experience. The regulations also
include recordkeeping requirements regarding the disposition of drugs,
records regarding individual case histories, and certain other
documentation verifying clinical investigators' fulfillment of
responsibilities.
Form FDA 1571 entitled ``Investigational New Drug Application
(IND)'' and Form FDA 1572 entitled ``Statement of Investigator,'' were
developed to assist respondents with the information collection and
provide for uniform reporting of required data elements. The
information is required to be submitted electronically. Individuals who
are interested in receiving printed forms may send an email request to
the FDA Forms Manager at [email protected]. Fees may apply.
Sponsors (including sponsor-investigators) interested in filing or
updating a research IND may use a new web-based interface developed for
use by mobile device or desktop to help in completing Form FDA 1571.
The web-based interface also allows respondents to electronically
submit completed Form FDA 1571 and associated files. For more
information regarding Forms FDA 1571 and 1572 visit https://www.fda.gov/news-events/expanded-access/how-complete-form-fda-1571-and-form-fda-1572.
Human drug, biological product, and device product submissions must
be accompanied by Form FDA 3674, as discussed in the guidance document
entitled ``Form FDA 3674--Certifications To Accompany Drug, Biological
Product, and Device Applications/Submissions'' (updated November 2017),
available from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/form-fda-3674-certifications-accompany-drug-biological-product-and-device-applicationssubmissions.
The guidance document provides procedural instruction on completing and
submitting required information to FDA. As communicated in the
instructions, the certification must accompany the application or
submission and be included at the time of submission to FDA.
Regulations in part 312, subpart B, specify content and format
requirements for applications, amendments, annual reporting, and
withdrawals, including content and format requirements for protocol and
information amendments. The regulations also explain phases of an
investigation and set forth principles of IND submissions.
Regulations in part 312, subpart C, describe administrative actions
pertaining to respondents' requests for and responses to clinical
holds, terminations, and inactive IND status determinations, as well as
various types of meetings (for example, End-of-Phase 2 and Pre-new drug
application (NDA) meetings).
Regulations in part 312, subpart D, set forth sponsor and
investigator responsibilities, including general responsibilities;
transfer of obligations to a contract research organization;
recordkeeping and record retention controls; reporting
responsibilities; and responsibility for disposition of unused supply
of investigational drug. The regulations also provide for investigator
controls including review of ongoing investigations; compliance with
requirements regarding the protection of human subjects and
institutional review board assurance; and disqualification of clinical
investigators.
Regulations in part 312, subpart E, sets forth requirements
applicable to drugs intended to treat life-threatening and severely
debilitating illnesses. The regulations establish procedures to reflect
that physicians and patients accept greater risk or side effects from
products that treat life-threatening and severely debilitating
illnesses than they would accept from products that treat less serious
illnesses. The procedures also reflect the recognition that the
benefits of the drug need to be evaluated in light of the severity of
the disease being treated.
Regulations in part 312, subpart F, include provisions pertaining
to import and export requirements; foreign clinical studies not
conducted under an IND; the disclosure of data and information in an
IND; and the issuance of guidance documents. We are revising the
information collection to account for burden that may be associated
with recommendations found in Agency guidance documents.
The guidance document entitled ``Oversight of Clinical
Investigations'' (August 2013) communicates risk-based monitoring
strategies and recommends plans for investigational studies of medical
products, including human drug and biological products, medical
devices, and combinations thereof. The guidance document is intended to
enhance human subject protection and the quality of clinical trial data
by focusing sponsor oversight on the most important aspects of study
conduct and reporting. The guidance also communicates that sponsors can
use a variety of approaches to fulfill
[[Page 9060]]
responsibilities for monitoring clinical investigator conduct and
performance in IND studies, and provides a description of strategies
for monitoring activities to reflect a modern, risk-based approach. The
guidance document recommends that respondents develop a written
comprehensive monitoring plan and describes monitoring approaches for
respondents to consider (Guidance Section IV.D.).
The guidance document entitled ``Pharmacogenomic Data
Submissions'' (March 2005) provides recommendations intended to assist
sponsors submitting or holding INDs, NDAs, or biologics license
applications (BLAs) with submission requirements for relevant data
regarding drug safety and effectiveness (including Sec. Sec. 312.22,
312.23, 312.31, 312.33, 314.50, 314.81, 601.2, and 601.12 (21 CFR
312.22, 312.23, 312.31, 312.33, 314.50, 314.81, 601.2 and 601.12)).
Because the regulations were developed before the advent of widespread
animal or human genetic or gene expression testing, the regulations do
not specifically address when such data must be submitted. The guidance
document includes content and format recommendations regarding
pharmacogenomic data submissions. Although we have not received any
pharmacogenomic submissions since 2013, we assume an average of 50
hours for preparing and providing information to FDA as recommended in
the guidance and estimate one submission annually.
The guidance document entitled ``Adaptive Designs for
Clinical Trials of Drugs and Biologics'' (December 2019) was developed
to assist sponsors and applicants submitting INDs, NDAs, BLAs, or
supplemental applications on the appropriate use of adaptive designs
for clinical trials to provide evidence of the effectiveness and safety
of a drug or biologic. The guidance document describes important
principles for designing, conducting, and reporting the results from an
adaptive clinical trial, and advises sponsors on the types of
information to submit to facilitate FDA evaluation of clinical trials
with adaptive designs, including Bayesian adaptive and complex trials
that rely on computer simulations for their design. The guidance
document also helps to fulfill FDA Commitment Goals under the
Prescription Drug User Fee Act pertaining to the enhancement of
regulatory decision tools.
The referenced guidance documents are available for download from
our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents and were issued consistent with Sec. 312.145 to
help respondents comply with requirements in part 312. In publishing
the respective notices of availability for each guidance document, we
included an analysis under the PRA and invited public comment on the
associated information collection recommendations. In addition, all
Agency guidance documents are issued in accordance with our Good
Guidance Practice regulations in 21 CFR 10.115, which provide for
public comment at any time.
Regulations in part 312, subpart G, provide for drugs for
investigational use in laboratory research animals or in vitro tests.
In the Federal Register of November 24, 2021 (86 FR 67060), we
published a 60-day notice requesting public comment on the proposed
collection of information. Although we received two general comments,
neither discussed the four information collection topics solicited in
our 60-day notice or suggested that we revise our burden estimate.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden for Biologics \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Subpart A--General Provisions: Sec. Sec. 312.1 through 312.10
----------------------------------------------------------------------------------------------------------------
Sec. 312.2(e); requests for 454 1.528 694 24 16,656
FDA advice on the applicability
of part 312 to a planned
clinical investigation.........
Sec. 312.8; requests to charge 14 1.64 23 48 1,104
for an investigational drug....
Sec. 312.10; waiver requests.. 5 1 5 24 120
-------------------------------------------------------------------------------
Subtotal Subpart A Center .............. .............. 722 .............. 17,880
for Biologics Evaluation
and Research (CBER)........
----------------------------------------------------------------------------------------------------------------
Subpart B--Investigational New Drug Application (IND): Sec. Sec. 312.20 through 312.38 (Including Forms FDA
1571, 1572, and 3674)
----------------------------------------------------------------------------------------------------------------
Sec. 312.23(a) through (f); 2,075 3.382 7,018 300 2,105,400
IND content and format.........
Sec. 312.30(a) through (e); 1,781 4.6692 8,316 284 2,361,744
protocol amendments............
Sec. 312.31(b); information 169 2.48 419 100 41,900
amendments.....................
Sec. 312.32(c) and (d); IND 224 10.59 2,372 32 75,904
safety reports.................
Sec. 312.33(a) through (f); 971 2.2739 2,208 360 794,880
IND annual reports.............
Sec. 312.38(b) and (c); 712 3.057 2,177 28 60,956
notifications of withdrawal of
an IND.........................
-------------------------------------------------------------------------------
Subtotal Subpart B CBER..... .............. .............. 22,510 .............. 5,440,784
----------------------------------------------------------------------------------------------------------------
Subpart C--Administrative Actions: Sec. Sec. 312.40 through 312.48
----------------------------------------------------------------------------------------------------------------
Sec. 312.42; clinical holds 154 1.65 254 284 72,136
and requests for modification..
Sec. 312.44(c) and (d); 86 1.22 105 16 1,680
sponsor responses to FDA when
IND is terminated..............
Sec. 312.45(a) and (b); 48 1.48 71 12 852
sponsor requests for or
responses to an inactive status
determination of an IND by FDA.
Sec. 312.47; meetings, 157 1.80 283 160 45,280
including ``End-of-Phase 2''
meetings and ``Pre-NDA''
meetings.......................
-------------------------------------------------------------------------------
Subtotal Subpart C CBER..... .............. .............. 713 .............. 119,948
----------------------------------------------------------------------------------------------------------------
[[Page 9061]]
Subpart D--Responsibilities of Sponsors and Investigators: Sec. Sec. 312.50 through 312.70
----------------------------------------------------------------------------------------------------------------
Sec. 312.53(c); investigator 1,068 5.23 5,586 80 446,880
reports submitted to the
sponsor, including Form FDA
1572, curriculum vitae,
clinical protocol, and
financial disclosure...........
Sec. 312.54(a); sponsor 4 4.25 17 48 816
submissions to FDA concerning
investigations involving an
exception from informed consent
under Sec. 50.24.............
Sec. 312.54(b); sponsor 1 1 1 48 48
notifications to FDA and others
concerning an institutional
review board determination that
it cannot approve research
because it does not meet the
criteria in the exception from
informed consent in Sec.
50.24(a).......................
Sec. 312.55(a); number of 473 2.224 1,052 48 50,496
investigator brochures
submitted by the sponsor to
each investigator..............
Sec. 312.55(b); number of 243 4.95 1,203 48 57,744
sponsor reports to
investigators on new
observations, especially
adverse reactions and safe use.
Sec. 312.56(b), (c), and (d); 915 2.948 2,698 80 215,840
review of ongoing
investigations and associated
notifications; sponsor
notifications..................
Sec. 312.58; inspection of 7 1 7 8 56
records and reports by FDA.....
Sec. 312.64; number of 2,728 3.816 10,411 24 249,864
investigator reports to the
sponsor, including progress
reports, safety reports, final
reports, and financial
disclosure reports.............
Sec. 312.70; disqualification 5 1 5 40 200
of a clinical investigator by
FDA............................
-------------------------------------------------------------------------------
Subtotal Subpart D CBER..... .............. .............. 20,980 .............. 1,021,944
----------------------------------------------------------------------------------------------------------------
Subpart F--Miscellaneous: Sec. Sec. 312.110 through 312.145
----------------------------------------------------------------------------------------------------------------
Sec. 312.110(b)(4) and (b)(5); 18 1 18 75 1,350
number of written
certifications and written
statements submitted to FDA
relating to the export of an
investigational drug...........
Sec. 312.120(b); number of 280 9.82 2,750 32 88,000
submissions to FDA of
``supporting information''
related to the use of foreign
clinical studies not conducted
under an IND...................
Sec. 312.120(c); number of 7 2.29 16 24 384
waiver requests submitted to
FDA related to the use of
foreign clinical studies not
conducted under an IND.........
Sec. 312.130; number of 350 1.342 470 8 3,760
requests for disclosable
information in an IND and for
investigations involving an
exception from informed consent
under Sec. 50.24.............
-------------------------------------------------------------------------------
Subtotal Subpart F CBER..... .............. .............. 3,254 .............. 93,494
===============================================================================
Total................... .............. .............. 48,179 .............. 6,694,050
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden for Biologics \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section; activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Subpart D--Responsibilities of Sponsors and Investigators: Sec. Sec. 312.50 through 312.70
----------------------------------------------------------------------------------------------------------------
Sec. 312.52(a); sponsor 94 2.26 212 2............... 424
records for the transfer of
obligations to a contract
research organization.
Sec. 312.57; sponsor 335 2.70 904 100............. 90,400
recordkeeping showing the
receipt, shipment, or other
disposition of the
investigational drug, and any
financial interest.
Sec. 312.62(a); investigator 453 1 453 40.............. 18,120
recordkeeping of the
disposition of drugs.
Sec. 312.62(b); investigator 453 1 453 40.............. 18,120
recordkeeping of case
histories of individuals.
---------------------------------------------------------------------------------
Subtotal Subpart D CBER... .............. .............. 2,022 ................ 127,064
----------------------------------------------------------------------------------------------------------------
[[Page 9062]]
Subpart G--Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests
----------------------------------------------------------------------------------------------------------------
Sec. 312.160(a)(3); records 111 1.40 155 0.5 (30 minutes) 78
pertaining to the shipment of
drugs for investigational use
in laboratory research
animals or in vitro tests.
Sec. 312.160(c) shipper 111 1.40 155 0.5 (30 minutes) 78
records of alternative
disposition of unused drugs.
---------------------------------------------------------------------------------
Subtotal Subpart G CBER... .............. .............. 310 ................ 156
=================================================================================
Total................. .............. .............. 2,332 ................ 127,220
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 3--Estimated Annual Reporting Burden for Human Drugs \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section; activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Subpart A--General Provisions
----------------------------------------------------------------------------------------------------------------
Sec. 312.2(e); requests for 419 1 419 24 10,056
FDA advice on the applicability
of part 312 to a planned
clinical investigation.........
Sec. 312.8; requests to charge 25 1.28 32 48 1,536
for an investigational drug....
Sec. 312.10; requests to waive 68 1.5 102 24 2,448
a requirement in part 312......
-------------------------------------------------------------------------------
Subtotal Subpart A Center .............. .............. 553 .............. 14,040
for Drug Evaluation and
Research (CDER)............
----------------------------------------------------------------------------------------------------------------
Subpart B--Investigational New Drug Application (IND)
----------------------------------------------------------------------------------------------------------------
Sec. 312.23(a) through (f); 4,886 1.4662 7,164 300 2,149,200
IND content and format
(including Forms FDA 1571 and
3674)..........................
Sec. 312.30(a) through (e); 11,847 3.2367 38,346 284.25 10,899,850
protocol amendments............
Sec. 312.31(b); information 8,094 3.30899 26,783 100 2,678,300
amendments.....................
Sec. 312.32(c) and (d); IND 892 15.848 14,137 32 452,384
safety reports.................
Sec. 312.33(a) through (f); 3,777 2.9097 10,990 360 3,956,400
IND annual reports.............
Sec. 312.38(b) and (c); 1,549 1.834 2,841 28 79,548
notifications of withdrawal of
an IND.........................
-------------------------------------------------------------------------------
Subtotal Subpart B CDER..... .............. .............. 100,261 .............. 20,215,682
----------------------------------------------------------------------------------------------------------------
Subpart C--Administrative Actions: Sec. Sec. 312.40 through 312.48
----------------------------------------------------------------------------------------------------------------
Sec. 312.42; clinical holds 181 1.28 232 284 65,888
and requests for modifications.
Sec. 312.44(c) and (d); 1 1 1 16 16
sponsor responses to FDA when
IND is terminated..............
Sec. 312.45(a) and (b); 213 1.72 367 12 4,404
sponsor requests for or
responses to an inactive status
determination of an IND by FDA.
Sec. 312.47; meetings, 174 2.885 502 160 80,320
including ``End-of-Phase 2''
meetings and ``Pre-NDA''
meetings.......................
-------------------------------------------------------------------------------
Subtotal Subpart C CDER..... .............. .............. 1,102 .............. 150,628
----------------------------------------------------------------------------------------------------------------
Subpart D--Responsibilities of Sponsors and Investigators
----------------------------------------------------------------------------------------------------------------
Sec. 312.54(a); sponsor 7 1.14 8 48 384
submissions to FDA concerning
investigations involving an
exception from informed consent
under Sec. 50.24.............
Sec. 312.54(b); sponsor 2 1 2 48 96
notifications to FDA and others
concerning an institutional
review board determination that
it cannot approve research
because it does not meet the
criteria in the exception from
informed consent in Sec.
50.24(a).......................
Sec. 312.56; review of ongoing 4,570 5.4689 24,993 80 1,999,440
investigations and associated
notifications..................
Sec. 312.58; inspection of 73 1 73 8 584
records and reports by FDA.....
Sec. 312.70; disqualification 5 1 5 40 200
of a clinical investigator by
FDA............................
-------------------------------------------------------------------------------
Subtotal Subpart D CDER..... .............. .............. 25,081 .............. 2,000,704
----------------------------------------------------------------------------------------------------------------
[[Page 9063]]
Subpart F--Miscellaneous: Sec. Sec. 312.110 through 312.145
----------------------------------------------------------------------------------------------------------------
Sec. 312.110(b)(4) and (b)(5); 8 22.375 179 75 13,425
written certifications and
written statements submitted to
FDA relating to the export of
an investigational drug........
Sec. 312.120(b); submissions 1,964 7.352 14,440 32 462,080
to FDA of ``supporting
information'' related to the
use of foreign clinical studies
not conducted under an IND.....
Sec. 312.120(c); waiver 68 1.5 102 24 2,448
requests submitted to FDA
related to the use of foreign
clinical studies not conducted
under an IND...................
Sec. 312.130; requests for 3 1 3 8 24
disclosable information in an
IND and for investigations
involving an exception from
informed consent under Sec.
50.24..........................
Sec. 312.145; Guidance
Documents:
Oversight of Clinical 88 1.5 132 4 528
Investigations (2013)......
Pharmacogenomic Data 1 1 1 50 50
Submissions (2005).........
Adaptive Designs for 55 4.727 260 50 13,000
Clinical Trials of Drugs
and Biologics (2019).......
-------------------------------------------------------------------------------
Subtotal Subpart F CDER... .............. .............. 15,117 .............. 491,555
===============================================================================
Total................... .............. .............. 142,114 .............. 22,872,609
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 4--Estimated Annual Recordkeeping Burden for Human Drugs \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section; activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Subpart D--Responsibilities of Sponsors and Investigators
----------------------------------------------------------------------------------------------------------------
Sec. 312.52(a); transfer of 466 3.107 1,448 300............. 434,400
obligations to a contract
research organization.
Sec. 312.57; records showing 13,000 1 13,000 100............. 1,300,000
the receipt, shipment, or
other disposition of the
investigational drug and any
financial interests.
Sec. 312.62(a); records on 13,000 1 13,000 40.............. 520,000
disposition of drugs.
Sec. 312.62(b); records on 2,192 6.587 14,439 40.............. 577,560
case histories of individuals.
---------------------------------------------------------------------------------
Subtotal Subpart D CDER... .............. .............. 41,887 ................ 2,831,960
----------------------------------------------------------------------------------------------------------------
Subpart G--Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests
----------------------------------------------------------------------------------------------------------------
Sec. 312.160(a)(3); records 547 1.43 782 0.50 (30 391
pertaining to the shipment of minutes).
drugs for investigational use
in laboratory research
animals or in vitro tests.
Sec. 312.160(c); shipper 547 1.43 782 0.50 (30 391
records of alternative minutes).
disposition of unused drugs.
---------------------------------------------------------------------------------
Subtotal................ .............. .............. 1,564 ................ 782
=================================================================================
Total................. .............. .............. 43,451 ................ 2,832,742
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The information collection reflects program changes and
adjustments. We have revised the information collection to account for
burden that may be incurred by respondents who choose to adopt or
implement recommendations discussed in referenced Agency guidance
documents intended to assist respondents in complying with regulatory
requirements in part 312. We have also made adjustments to individual
collection elements, specifically with regard to protocol amendments
and emergency INDs for both human drugs and biological drugs. We
attribute the increase for these elements to a corresponding increase
in submissions since last OMB review and approval of the information
collection and the ongoing public health emergency. Finally, we have
removed burden we attribute to provisions in part 312, subpart I:
Expanded Access to Investigational Drugs for Treatment Use and are
revising OMB control number 0910-0814 to include burden associated with
information collection applicable
[[Page 9064]]
to these regulatory provisions for efficiency of Agency operations. As
a result of these cumulative changes and adjustments, the information
collection reflects an overall decrease in both annual responses and
burden hours.
Dated: February 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03432 Filed 2-16-22; 8:45 am]
BILLING CODE 4164-01-P
