Document ID: FDA-2014-N-1721-0010
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Applications
Posted Date: 2018-10-04T04:00Z

[Federal Register Volume 83, Number 193 (Thursday, October 4, 2018)]
[Notices]
[Pages 50102-50107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21610]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1721]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Investigational New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on regulations under which the 
clinical investigation of the safety and effectiveness of unapproved 
new drugs and biological products can be conducted.

DATES: Submit either electronic or written comments on the collection 
of information by December 3, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before December 3, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 3, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-N-1721 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Investigational New Drug 
Applications.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this

[[Page 50103]]

information on the cover sheet and not in the body of your comments and 
you must identify this information as ``confidential.'' Any information 
marked as ``confidential'' will not be disclosed except in accordance 
with 21 CFR 10.20 and other applicable disclosure law. For more 
information about FDA's posting of comments to public dockets, see 80 
FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Investigational New Drug Application--21 CFR Part 312

OMB Control Number 0910-0014--Extension

    This information collection supports FDA regulations in 21 CFR part 
312 covering Investigational New Drugs. Part 312 implements provisions 
of section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 355(i)) to issue regulations under which the clinical 
investigation of the safety and effectiveness of unapproved new drugs 
and biological products can be conducted.
    FDA is charged with implementing statutory requirements that ensure 
drug products marketed in the United States are shown to be safe and 
effective, properly manufactured, and properly labeled for their 
intended uses. Section 505(a) of the FD&C Act (21 U.S.C. 355(a)) 
provides that a new drug may not be introduced or delivered for 
introduction into interstate commerce in the United States unless FDA 
has previously approved a new drug application (NDA). FDA approves an 
NDA only if the sponsor of the application first demonstrates that the 
drug is safe and effective for the conditions prescribed, recommended, 
or suggested in the product's labeling. Proof must consist, in part, of 
adequate and well-controlled studies, including studies in humans, that 
are conducted by qualified experts.
    The investigational new drug application (IND) regulations under 21 
CFR part 312 establish reporting requirements that include an initial 
application as well as amendments to that application, reports on 
significant revisions of clinical investigation plans, and information 
on a drug's safety or effectiveness. In addition, the sponsor is 
required to give FDA an annual summary of the previous year's clinical 
experience. The regulations also include recordkeeping requirements 
pertaining to the disposition of drugs, records pertaining to 
individual case histories, and certain other documentation verifying 
the fulfillment of responsibilities by clinical investigators.
    Submissions are reviewed by medical officers and other Agency 
scientific reviewers assigned responsibility for overseeing a specific 
study. The details and complexity of these requirements are dictated by 
the scientific procedures and human subject safeguards that must be 
followed in the clinical tests of investigational new drugs.
    The IND information collection requirements provide the means by 
which FDA can monitor the clinical investigation of the safety and 
effectiveness of unapproved new drugs and biological products, 
including the following: (1) Monitor the safety of ongoing clinical 
investigations; (2) determine whether the clinical testing of a drug 
should be authorized; (3) ensure production of reliable data on the 
metabolism and pharmacological action of the drug in humans; (4) obtain 
timely information on adverse reactions to the drug; (5) obtain 
information on side effects associated with increasing doses; (6) 
obtain information on the drug's effectiveness; (7) ensure the design 
of well-controlled, scientifically valid studies; and (8) obtain other 
information pertinent to determining whether clinical testing should be 
continued and information related to the protection of human subjects. 
Without the information provided by industry as required under the IND 
regulations, FDA cannot authorize or monitor the clinical 
investigations that must be conducted before authorizing the sale and 
general use of new drugs. These reports enable FDA to monitor a study's 
progress, to ensure the safety of subjects, to ensure that a study will 
be conducted ethically, and to increase the likelihood that the sponsor 
will conduct studies that will be useful in determining whether the 
drug should be marketed and available for use in medical practice.
    To assist respondents with certain reporting requirements under 
part 312, we have developed two forms: Form FDA 1571 entitled, 
``Investigational New Drug Application (IND)'' and Form FDA 1572 
entitled, ``Statement of Investigator.'' Anyone who intends to conduct 
a clinical investigation must submit Form FDA 1571 as instructed. The 
reporting elements include: (1) A cover sheet containing background 
information on the sponsor and investigator; (2) a table of contents; 
(3) an introductory statement and general investigational plan; (4) an 
investigator's brochure describing the drug substance; (5) a protocol 
for each planned study; (6) chemistry, manufacturing, and control 
information for each investigation; (7) pharmacology and toxicology 
information for each investigation; and (8) previous human experience 
with the investigational drug. Form FDA 1572 is executed and submitted 
by the IND sponsor before an investigator may participate in an

[[Page 50104]]

investigation. It includes background information on the investigator 
as well as the investigation, and a general outline of the planned 
investigation and study protocol.
    Below, we estimate the burden of the information collection as 
reported by FDA's Center for Drug Evaluation and Research (CDER) and 
Center for Biologics Evaluation and Research (CBER) as follows:

                      Table 1--Estimated Annual Reporting Burden for Human Drugs (CDER) \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Sec.   312.2(e); Requests for                400               1             400              24           9,600
 FDA advice on the applicability
 of part 312 to a planned
 clinical investigation.........
Sec.   312.8; Requests to charge              74            1.23              91              48           4,368
 for an investigational drug....
Sec.   312.10; Requests to waive              86            1.84             158              24           3,792
 a requirement in part 312......
Sec.   312.23(a) through (f);              2,187             1.7           3,718           1,600       5,948,800
 IND content and format
 (including Form FDA 1571)......
Sec.   312.30(a) through (e);              4,418            5.52          24,387             284       6,925,908
 Protocol amendments............
Sec.   312.31(b); Information              6,691            3.32          22,214             100       2,221,400
 amendments.....................
Sec.   312.32(c) and (d); IND                867           15.78          13,681              32         437,792
 safety reports.................
Sec.   312.33(a) through (f);              3,376            2.86           9,655             360       3,475,800
 IND annual reports.............
Sec.   312.38(b) and (c);                    930            1.61           1,497              28          41,916
 Notifications of withdrawal of
 an IND.........................
Sec.   312.42; Sponsor requests              198            1.38             273             284          77,532
 that a clinical hold be
 removed, including sponsor
 submission of a complete
 response to the issues
 identified in the clinical hold
 order..........................
Sec.   312.44(c) and (d);                     12            1.16              14              16             224
 Sponsor responses to FDA when
 IND is terminated..............
Sec.   312.45(a) and (b);                    231            1.84             425              12           5,100
 Sponsor requests for or
 responses to an inactive status
 determination of an IND by FDA.
Sec.   312.47; Meetings,                     122            1.51             184             160          29,440
 including ``End-of-Phase 2''
 meetings and ``Pre-NDA''
 meetings.......................
Sec.   312.54(a); Sponsor                     15             2.4              36              48           1,728
 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 IRB 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(b), (c), and (d);            6,100               7          42,700              80       3,416,000
 Sponsor notifications to FDA
 and others resulting from: (1)
 The sponsor's monitoring of all
 clinical investigations and
 determining that an
 investigator is not in
 compliance with the
 investigation agreements; (2)
 the sponsor's review and
 evaluation of the evidence
 relating to the safety and
 effectiveness of the
 investigational drug; and (3)
 the sponsor's determination
 that the investigational drug
 presents an unreasonable and
 significant risk to subjects...
Sec.   312.58(a); Sponsor's                   73               1              73               8             584
 submissions of clinical
 investigation records to FDA on
 request during FDA inspections.
Sec.   312.70; During the                      4               1               4              40             160
 disqualification process of a
 clinical investigator by FDA,
 the number of investigator
 responses or requests to FDA
 following FDA's notification to
 an investigator of its failure
 to comply with investigation
 requirements...................
Sec.   312.110(b)(4) and (b)(5);              11           26.28             289              75          21,675
 Written certifications and
 written statements submitted to
 FDA relating to the export of
 an investigational drug........
Sec.   312.120(b); Submissions             1,414            8.62          12,189              32         390,048
 to FDA of ``supporting
 information'' related to the
 use of foreign clinical studies
 not conducted under an IND.....
Sec.   312.120(c); Waiver                     35            2.34              82              24           1,968
 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.  Sec.   312.310(b) and                  935            2.77           2,590               8          20,720
 312.305(b); Submissions related
 to expanded access and
 treatment of an individual
 patient........................
Sec.   312.310(d); Submissions               480            2.15           1,032              16          16,512
 related to emergency use of an
 investigational new drug.......
Sec.  Sec.   312.315(c) and                  118            2.52             297             120          35,640
 312.305(b); Submissions related
 to expanded access and
 treatment of an intermediate-
 size patient population........
Sec.   312.320(b); Submissions                10            12.9             129             300          38,700
 related to a treatment IND or
 treatment protocol.............
                                 -------------------------------------------------------------------------------

[[Page 50105]]

 
    Total.......................  ..............  ..............  ..............  ..............      23,125,527
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                    Table 2--Estimated Annual Recordkeeping Burden for Human Drugs (CDER) \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
         21 CFR section              Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Sec.   312.52(a); Sponsor                  1,300               1           1,300               2           2,600
 records for the transfer of
 obligations to a contract
 research organization..........
Sec.   312.57; Sponsor                    13,000               1          13,000             100       1,300,000
 recordkeeping showing the
 receipt, shipment, or other
 disposition of the
 investigational drug and any
 financial interests............
Sec.   312.62(a); Investigator            13,000               1          13,000              40         520,000
 recordkeeping of the
 disposition of drugs...........
Sec.   312.62(b); Investigator            13,000               1          13,000              40         520,000
 recordkeeping of case histories
 of individuals.................
Sec.   312.160(a)(3); Records                547            1.43             782          * 0.50             391
 pertaining to the shipment of
 drugs for investigational use
 in laboratory research animals
 or in vitro tests..............
Sec.   312.160(c); Shipper                   547            1.43             782          * 0.50             391
 records of alternative
 disposition of unused drugs....
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       2,343,382
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
* 30 minutes.

               Table 3--Estimated Annual Third-Party Disclosure Burden for Human Drugs (CDER) \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of      disclosures    Total annual   Average burden    Total hours
                                    respondents   per respondent    disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
Sec.   312.53(c); Investigator             1,732            7.94          13,752              80       1,100,160
 reports submitted to the
 sponsor, including Form FDA
 1572, curriculum vitae,
 clinical protocol, and
 financial disclosure...........
Sec.   312.55(a); Investigator               995               4           3,980              48         191,040
 brochures submitted by the
 sponsor to each investigator...
Sec.   312.55(b); Sponsor                    995               4           3,980              48         191,040
 reports to investigators on new
 observations, especially
 adverse reactions and safe use.
Sec.   312.64; Investigator               13,000               1          13,000              24         312,000
 reports to the sponsor,
 including progress reports,
 safety reports, final reports,
 and financial disclosure
 reports........................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       1,794,240
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                       Table 4--Estimated Annual Reporting Burden for Biologics (CBER) \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
312.2(e) Requests for FDA advice             217            1.18             256              24           6,144
 on the applicability of part
 312 to a planned clinical
 investigation..................
312.8 Requests to charge for an               20            1.50              30              48           1,440
 investigational drug...........
312.10 Requests to waive a                     2               1               2              24              48
 requirement in part 312........
312.23(a) through (f) IND                    335            1.35             452           1,600         723,200
 content and format.............
312.30(a) through (e) Protocol               694            5.84           4,053             284       1,151,052
 amendments.....................
312.31(b) Information amendments              77            2.43             187             100          18,700
312.32(c) and (d) IND Safety                 161            8.83           1,422              32          45,504
 reports........................
312.33(a) through (f) IND Annual             745            2.14           1,594             360         573,840
 reports........................
312.38(b) and (c) Notifications              134            1.69             226              28           6,328
 of withdrawal of an IND........

[[Page 50106]]

 
312.42 Sponsor requests that a                67            1.30              87             284          24,708
 clinical hold be removed,
 including sponsor submission of
 a complete response to the
 issues identified in the
 clinical hold order............
312.44(c) and (d) Sponsor                     34            1.15              39              16             624
 responses to FDA when IND is
 terminated.....................
312.45(a) and (b) Sponsor                     55            1.38              76              12             912
 requests for or responses to an
 inactive status determination
 of an IND by FDA...............
312.47 Meetings, including ``End-             88            1.75             154             160          24,640
 of-Phase 2'' meetings and ``Pre-
 NDA'' meetings.................
312.53(c) Investigator reports               453            6.33           2,867              80         229,360
 submitted to the sponsor,
 including Form FDA-1572,
 curriculum vitae, clinical
 protocol, and financial
 disclosure.....................
312.54(a) Sponsor submissions to               1               1               1              48              48
 FDA concerning investigations
 involving an exception from
 informed consent under 21 CFR
 50.24..........................
312.54(b) Sponsor notifications                1               1               1              48              48
 to FDA and others concerning an
 IRB 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             239            1.91             456              48          21,888
 brochures submitted by the
 sponsor to each investigator...
312.55(b) Number of sponsor                  243            4.95           1,203              48          57,744
 reports to investigators on new
 observations, especially
 adverse reactions and safe use.
312.56(b), (c), and (d) Sponsor              108            2.21             239              80          19,120
 notifications to FDA and others
 resulting from: (1) The
 sponsor's monitoring of all
 clinical investigations and
 determining that an
 investigator is not in
 compliance with the
 investigation agreements; (2)
 the sponsor's review and
 evaluation of the evidence
 relating to the safety and
 effectiveness of the
 investigational drug; and (3)
 the sponsor's determination
 that the investigational drug
 presents an unreasonable and
 significant risk to subjects...
312.58(a) Number of sponsor's                  7               1               7               8              56
 submissions of clinical
 investigation records to FDA on
 request during FDA inspections.
312.64 Number of investigator              2,728            3.82          10,421              24         250,104
 reports to the sponsor,
 including progress reports,
 safety reports, final reports,
 and financial disclosure
 reports........................
312.70 During the                              5               1               5              40             200
 disqualification process of a
 clinical investigator by FDA,
 the number of investigator
 responses or requests to FDA
 following FDA's notification to
 an investigator of its failure
 to comply with investigation
 requirements...................
312.110(b)(4) and (b)(5) Number               18               1              18              75           1,350
 of written certifications and
 written statements submitted to
 FDA relating to the export of
 an investigational drug........
312.120(b) Number of submissions             280            9.82           2,750              32          88,000
 to FDA of ``supporting
 information'' related to the
 use of foreign clinical studies
 not conducted under an IND.....
312.120(c) Number of waiver                    7            2.29              16              24             384
 requests submitted to FDA
 related to the use of foreign
 clinical studies not conducted
 under an IND...................
312.130 Number of requests for               350            1.34             469               8           3,752
 disclosable information in an
 IND and for investigations
 involving an exception from
 informed consent under Sec.
 50.24..........................
312.310(b) and 312.305(b) Number              78            1.08              84               8             672
 of submissions related to
 expanded access and treatment
 of an individual patient.......
312.310(d) Number of submissions              76            2.76             210              16           3,360
 related to emergency use of an
 investigational new drug.......
312.315(c) and 312.305(b) Number               9               1               9             120           1,080
 of submissions related to
 expanded access and treatment
 of an intermediate-size patient
 population.....................
312.320(b) Number of submissions               1               1               1             300             300
 related to a treatment IND or
 treatment protocol.............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       3,254,606
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

[[Page 50107]]

                     Table 5--Estimated Annual Recordkeeping Burden for Biologics (CBER) \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
         21 CFR section              Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
312.52(a) Sponsor records for                 75            1.40             105               2             210
 the transfer of obligations to
 a contract research
 organization...................
312.57 Sponsor recordkeeping                 335            2.70             904             100          90,400
 showing the receipt, shipment,
 or other disposition of the
 investigational drug, and any
 financial interests............
312.62(a) Investigator                       453               1             453              40          18,120
 recordkeeping of the
 disposition of drugs...........
312.62(b) Investigator                       453               1             453              40          18,120
 recordkeeping of case histories
 of individuals.................
312.160(a)(3) Records pertaining             111            1.40             155           * 0.5              78
 to the shipment of drugs for
 investigational use in
 laboratory research animals or
 in vitro tests.................
312.160(c) Shipper records of                111            1.40             155           * 0.5              78
 alternative disposition of
 unused drugs...................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         127,006
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
* 30 minutes.

    Because we have received an increased number of IND submissions 
since the last OMB approval of the information collection, we have 
increased our estimate of the associated burden accordingly.

    Dated: September 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21610 Filed 10-3-18; 8:45 am]
 BILLING CODE 4164-01-P