Notice2022-03432
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational New Drug Application Regulations
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Published
February 17, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 33 (Thursday, February 17, 2022)</title>
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[Federal Register Volume 87, Number 33 (Thursday, February 17, 2022)]
[Notices]
[Pages 9058-9064]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-03432]
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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.
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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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#0c5c5e4d5f786d6a6a4c6a686d2264647f226b637a"><span class="__cf_email__" data-cfemail="104042514364717676507674713e7878633e777f66">[email protected]</span></a>.
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:
<bullet> 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.
<bullet> 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.
<bullet> 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 (<a href="https://clinicaltrials.gov">https://clinicaltrials.gov</a>) 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 <a href="/cdn-cgi/l/email-protection#50363f223d233d313e31373522101f137e1614117e171f06"><span class="__cf_email__" data-cfemail="98fef7eaf5ebf5f9f6f9fffdead8d7dbb6dedcd9b6dfd7ce">[email protected]</span></a>. 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 <a href="https://www.fda.gov/news-events/expanded-access/how-complete-form-fda-1571-and-form-fda-1572">https://www.fda.gov/news-events/expanded-access/how-complete-form-fda-1571-and-form-fda-1572</a>.
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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/form-fda-3674-certifications-accompany-drug-biological-product-and-device-applicationssubmissions">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/form-fda-3674-certifications-accompany-drug-biological-product-and-device-applicationssubmissions</a>.
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.
<bullet> 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.).
<bullet> 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.
<bullet> 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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a> 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
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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.........................
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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............................
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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
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[[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.
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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......
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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.........................
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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............................
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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
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