[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, 
<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 (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 <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 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.
    <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 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


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