Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational New Drug Applications, 11449-11454 [2015-04379]
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11449
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
responses per
respondent
Number of
respondents
21 CFR section
Total annual
responses
Average burden per response
Total hours
610.47(a)(3) ......................................
610.47(b)(3) ......................................
630.6(a) 3 ...........................................
630.6(a) 4 ...........................................
630.6(d)(1) ........................................
1,945
4,961
648
84
63
12.03
0.41
668.72
53.57
35.71
23,400
2,050
433,333
4,500
2,250
0.17 (10 minutes) .............................
1 .......................................................
0.08 (5 minutes) ...............................
1.5 (90 minutes) ...............................
1 .......................................................
3,978
2,050
34,667
6,750
2,250
Total ...........................................
........................
........................
........................
...........................................................
61,043
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 ×
4,961 + 2,361 = 366).
3 Notification of donors determined not to be eligible for donation based on failure to satisfy eligibility criteria.
4 Notification of donors deferred based on reactive test results for evidence of infection due to communicable disease agents.
2 Five
Dated: February 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
[FR Doc. 2015–04381 Filed 3–2–15; 8:45 am]
BILLING CODE 4164–01–P
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 Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by April 2,
2015.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0014. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
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SUMMARY:
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Investigational New Drug (IND)
Regulations—21 CFR Part 312 (OMB
Control Number 0910–0014)—Extension
FDA is requesting OMB approval for
the reporting and recordkeeping
requirements contained in FDA
regulations entitled ‘‘Investigational
New Drug Application’’ in part 312 (21
CFR part 312). Part 312 implements
provisions of section 505(i) of the
Federal Food, Drug, and Cosmetic Act
(the 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 drug
products marketed in the United States
be shown to be safe and effective,
properly manufactured, and properly
labeled for their intended uses. Section
505(a) of the FD&C Act 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 IND
regulations establish reporting
requirements that include an initial
application as well as amendments to
that application, reports on significant
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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.
Submissions are reviewed by medical
officers and other Agency scientific
reviewers assigned responsibility for
overseeing the specific study. The IND
regulations also contain recordkeeping
requirements that pertain to the
responsibilities of sponsors and
investigators. The detail 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 which must be
conducted prior to authorizing the sale
and general use of new drugs. These
reports enable FDA to monitor a study’s
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progress, to assure subject safety, to
assure 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.
There are two forms that are required
under part 312:
Form FDA–1571—‘‘Investigational
New Drug Application.’’ A person who
intends to conduct a clinical
investigation submits this form to FDA.
It includes the following information:
(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—‘‘Investigator
Statement.’’ Before permitting an
investigator to begin participation in an
investigation, the sponsor must obtain
and record this form. It includes
background information on the
investigator and the investigation, and a
general outline of the planned
investigation and the study protocol.
FDA is requesting OMB approval for
the following reporting and
recordkeeping requirements in part 312.
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I. Reporting Requirements
Section 312.2(e)—Requests for FDA
advice on the applicability of part
312 to a planned clinical
investigation.
Section 312.6—Labeling of an
investigational new drug. Estimates
for the information collection in
this requirement are included under
§ 312.23(a)(7)(iv)(d).
Section 312.8—Charging for
investigational drugs under an IND.
Section 312.10—Applications for waiver
of requirements under part 312. As
indicated in § 312.10(a), estimates
for the information collection in
this requirement are included under
§§ 312.23 and 312.31. In addition,
other waiver requests under
§ 312.10 are estimated in table 1.
Section 312.20(c)—Applications for
investigations involving an
exception from informed consent
under § 50.24 (21 CFR 50.24).
Estimates for the information
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collection in this requirement are
included under § 312.23.
Section 312.23—IND (content and
format).
Section 312.23(a)(1)—Cover sheet FDA–
1571.
Section 312.23(a)(2)—Table of Contents.
Section 312.23(a)(3)—Investigational
plan for each planned study.
Section 312.23(a)(5)—Investigator’s
brochure.
Section 312.23(a)(6)—Protocols—Phase
1, 2, and 3.
Section 312.23(a)(7)—Chemistry,
manufacturing, and control
information.
Section 312.23(a)(7)(iv)(a),(b),(c)—A
description of the drug substance, a
list of all components, and any
placebo used.
Section 312.23(a)(7)(iv)(d)—Labeling:
Copies of labels and labeling to be
provided each investigator.
Section 312.23(a)(7)(iv)(e)—
Environmental impact analysis
regarding drug manufacturing and
use.
Section 312.23(a)(8)—Pharmacological
and toxicology information.
Section 312.23(a)(9)—Previous human
experience with the investigational
drug.
Section 312.23(a)(10)—Additional
information.
Section 312.23(a)(11)—Relevant
information.
Section 312.23(f)—Identification of
exception from informed consent.
Section 312.30—Protocol amendments.
§ 312.30(a)—New protocol
§ 312.30(b)—Changes in protocol
§ 312.30(c)—New investigator.
§ 312.30(d)—Content and format.
§ 312.30(e)—Frequency.
Section 312.31—Information
amendments.
§ 312.31(b)—Content and format.
— Chemistry, toxicology, or technical
information.
Section 312.32—Safety reports.
§ 312.32(c)(1)—Written reports to
FDA and to investigators.
§ 312.32(c)(2)—Telephone reports to
FDA for fatal or life-threatening
experience.
§ 312.32(c)(3)—Format or frequency.
§ 312.32(d)—Followup submissions.
Section 312.33—Annual reports.
§ 312.33(a)—Individual study
information.
§ 312.33(b)—Summary information.
§ 312.33(b)(1)—Adverse experiences.
§ 312.33(b)(2)—Safety report
summary.
§ 312.33(b)(3)—List of fatalities and
causes of death.
§ 312.33(b)(4)—List of discontinuing
subjects.
§ 312.33 (b)(5)—Drug action.
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§ 312.33 (b)(6)—Preclinical studies
and findings.
§ 312.33 (b)(7)—Significant changes.
§ 312.33(c)—Next year general
investigational plan.
§ 312.33(d)—Brochure revision.
§ 312.33(e)—Phase I protocol
modifications.
§ 312.33(f)—Foreign marketing
developments.
Section 312.38(b) and (c)—Notification
of withdrawal of an IND.
Section 312.41—Comment and advice
on an IND. Estimates for the
information collection in this
requirement are included under
§ 312.23.
Section 312.42—Sponsor requests that a
clinical hold be removed, and
submits a complete response to the
issues identified in the clinical hold
order.
Section 312.44(c) and (d)—Opportunity
for sponsor response to FDA when
IND is terminated.
Section 312.45(a) and (b)—Sponsor
request for, or response to, an
inactive status determination of an
IND.
Section 312.47—Meetings, including
‘‘End-of-Phase 2’’ meetings and
‘‘Pre-NDA’’ meetings.
Section 312.48—Dispute resolution.
Estimates for the information
collection in this requirement are
included under § 312.47.
Section 312.53(c)—Investigator
information. Investigator report
(Form FDA–1572) and narrative;
Investigator’s background
information; Phase 1 outline of
planned investigation and Phase 2
outline of study protocol.
Section 312.54(a) and (b)—Sponsor
submissions concerning
investigations involving an
exception from informed consent
under § 50.24.
§ 312.55(b)—Sponsor reports to
investigators on new observations,
especially adverse reactions and
safe use. Only ‘‘new observations’’
are estimated under this section;
investigator brochures are included
under § 312.23.
Section 312.56(b), (c), and (d)—Sponsor
monitoring of all clinical
investigations, investigators, and
drug safety; notification to FDA and
others.
Section 312.58(a)—Sponsor’s
submission of records to FDA on
request.
Section 312.64—Investigator reports to
the sponsor.
§ 312.64(a)—Progress reports.
§ 312.64(b)—Safety reports
§ 312.64(c)—Final reports.
§ 312.64(d)—Financial disclosure
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reports.
Section 312.66—Investigator reports to
institutional review board (IRB).
Estimates for the information
collection in this requirement are
included under § 312.53.
Section 312.70—Investigator
disqualification; opportunity to
respond to FDA.
Section 312.83—Sponsor submission of
treatment protocol. Estimates for
this requirement are included under
§ 312.320.
Section 312.85—Sponsors conducting
phase 4 studies. Estimates for the
information collection in this
requirement are included under
§ 312.23, and under §§ 314.50,
314.70, and 314.81 in OMB control
number 0910–0001.
Section 312.110(b)—Requests to export
an investigational drug.
Section 312.120—Submissions related
to foreign clinical studies not
conducted under an IND.
Section 312.130—Requests for
disclosable information in an IND
and from investigations involving
an exception from informed consent
under § 50.24.
Sections 312.310(b); 312.305(b)—
Submissions related to expanded
access and treatment of an
individual patient.
Section 312.310(d)—Submissions
related to emergency use of an
investigational new drug.
Sections 312.315(c); 312.305(b)—
Submissions related to expanded
access and treatment of an
intermediate-size patient
population.
Section 312.320—Submissions related
to a treatment IND or treatment
protocol.
II. Recordkeeping Requirements
Section 312.52(a)—Transfer of
obligations to a contract research
organization.
Section 312.57—Sponsor recordkeeping
on the investigational drug.
Section 312.59—Sponsor recordkeeping
of disposition of unused supply of
drugs. Estimates for the information
collection in this requirement are
included under § 312.57.
Section 312.62(a)—Investigator
recordkeeping of disposition of
drugs.
Section 312.62(b)—Investigator
recordkeeping of case histories of
individuals.
Section 312.120(d)—Recordkeeping
requirements for submissions
related to foreign clinical studies
not conducted under an IND.
Estimates for the information
collection in this requirement are
included under § 312.57.
Section 312.160(a)(3)—Records
pertaining to the shipment of drugs
for investigational use in laboratory
research animals or in vitro tests.
Section 312.160(c)—Shipper records of
alternative disposition of unused
drugs.
In the Federal Register of November
5, 2014 (79 FR 65663), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. FDA received 24
comments, however, these comments
did not address the information
collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1
mstockstill on DSK4VPTVN1PROD with NOTICES
312.2(e), Requests for FDA advice on the applicability of
part 312 to a planned clinical investigation ....................
312.8, Requests to charge for an investigational drug .....
312.10, Requests to waive a requirement in part 312 ......
312.23(a) through (f), IND content and format (including
Form FDA 1571) ............................................................
312.30(a) through (e), Protocol amendments ...................
312.31 (b), Information amendments ................................
312.32(c) and (d), IND Safety reports ...............................
312.33(a) through (f), IND Annual reports .........................
312.38(b) and (c), Notifications of withdrawal of an IND ..
312.42, Sponsor requests that a 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 responses to FDA when IND
is terminated ...................................................................
312.45(a) and (b), Sponsor requests for or responses to
an inactive status determination of an IND by FDA ......
312.47, Meetings, including ‘‘End-of-Phase 2’’ meetings
and ‘‘Pre-NDA’’ meetings ...............................................
312.53(c), Investigator reports submitted to the sponsor,
including Form FDA 1572, curriculum vitae, clinical
protocol, and financial disclosure. (Third party disclosure) ...............................................................................
312.54(a), Sponsor submissions to FDA concerning investigations involving an exception from informed consent under 21 CFR 50.24 ..............................................
312.54(b), Sponsor 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 § 50.24(a). (Includes
third party disclosure) .....................................................
312.55(a), Investigator brochures submitted by the sponsor to each investigator. (Third party disclosure) ..........
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Number of
responses per
respondent
Number of
respondents
21 CFR section
PO 00000
Frm 00065
Average
burden per
response
Total annual
responses
Total hours
800
56
50
1
1.25
1.76
800
70
88
24
48
24
19,200
3,360
2,112
1,689
3,739
4,537
755
2,877
862
1.57
5.77
3.39
24.28
2.76
1.54
2,648
21,588
15,377
18,332
7,953
1,328
1,600
284
100
32
360
28
4,236,800
6,130,992
1,537,700
586,624
2,863,080
37,184
158
1.30
205
284
58,220
12
16
192
12
1
260
1.73
451
12
5,412
225
1.86
419
160
67,040
1,444
8.38
12,087
80
966,960
7
5
35
48
1,680
7
1
7
48
336
2,067
48
99,216
590
Fmt 4703
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3.50
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1—Continued
312.55(b), Sponsor reports to investigators on new observations, especially adverse reactions and safe use.
(Third party disclosure) ..................................................
312.56(b),(c), and (d), 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. (Includes
third party disclosure) .....................................................
312.58(a), Sponsor’s submissions of clinical investigation
records to FDA on request during FDA inspections ......
312.64, Investigator reports to the sponsor, including
progress reports, safety reports, final reports, and financial disclosure reports. (Third party disclosure) .......
312.70, During the 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), Written certifications and written
statements submitted to FDA relating to the export of
an investigational drug ...................................................
312.120(b), Submissions to FDA of ‘‘supporting information’’ related to the use of foreign clinical studies not
conducted under an IND ................................................
312.120(c), Waiver requests submitted to FDA related to
the use of foreign clinical studies not conducted under
an IND ............................................................................
312.130, Requests for disclosable information in an IND
and for investigations involving an exception from informed consent under § 50.24 .......................................
312.310(b) and 312.305(b), Submissions related to expanded access and treatment of an individual patient ..
312.310(d), Submissions related to emergency use of an
investigational new drug .................................................
312.315(c) and 312.305(b), Submissions related to expanded access and treatment of an intermediate-size
patient population ...........................................................
312.320(b), Submissions related to a treatment IND or
treatment protocol ..........................................................
Total ............................................................................
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section
Average
burden per
response
Total annual
responses
Total hours
590
3.50
2,067
48
99,216
3,584
6.52
23,355
80
1,868,400
60
1
60
8
480
1,444
1
1,444
24
34,656
4
1
4
40
160
11
26.28
289
75
21,675
1,414
8.63
12,198
32
390,336
35
2.34
82
24
1,968
3
8
24
3
1
228
1.76
401
8
3,208
410
2.19
899
16
14,384
44
7.07
311
120
37,320
12
12.67
152
300
45,600
........................
..........................
........................
........................
19,134,039
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR HUMAN DRUGS 1
Number of
recordkeepers
mstockstill on DSK4VPTVN1PROD with NOTICES
21 CFR section
312.52(a), Sponsor records for the transfer of obligations
to a contract research organization ...............................
312.57, Sponsor recordkeeping showing the receipt,
shipment, or other disposition of the investigational
drug, and any financial interests ....................................
312.62(a), Investigator recordkeeping of the disposition
of drugs ..........................................................................
312.62(b), Investigator recordkeeping of case histories of
individuals .......................................................................
312.160(a)(3), Records pertaining to the shipment of
drugs for investigational use in laboratory research animals or in vitro tests .......................................................
312.160(c), Shipper records of alternative disposition of
unused drugs ..................................................................
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Number of
records per
recordkeeper
335
Total annual
records
1.50
Average
burden per
recordkeeping
Total hours
503
2
1,006
1,689
1
1,689
100
168,900
1,444
1
1,444
40
57,760
1,444
1
1,444
40
57,760
547
1.40
782
* 0.50
391
547
1.40
782
* 0.50
391
Fmt 4703
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TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR HUMAN DRUGS 1—Continued
Number of
recordkeepers
21 CFR section
Total ............................................................................
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
........................
..........................
........................
........................
Total hours
286,190
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
* Thirty (30) minutes.
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS 1
mstockstill on DSK4VPTVN1PROD with NOTICES
312.2(e), Requests for FDA advice on the applicability of
part 312 to a planned clinical investigation ....................
312.8, Requests to charge for an investigational drug .....
312.10, Requests to waive a requirement in part 312 ......
312.23(a) through (f), IND content and format ..................
312.30(a) through (e), Protocol amendments ...................
312.31(b), Information amendments ..................................
312.32(c) and (d), IND Safety reports ...............................
312.33(a) through (f), IND Annual reports .........................
312.38(b) and (c), Notifications of withdrawal of an IND ..
312.42, Sponsor requests that a 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 responses to FDA when IND
is terminated ...................................................................
312.45(a) and (b), Sponsor requests for or responses to
an inactive status determination of an IND by FDA ......
312.47, Meetings, including ‘‘End-of-Phase 2’’ meetings
and ‘‘Pre-NDA’’ meetings ...............................................
312.53(c), Investigator reports submitted to the sponsor,
including Form FDA–1572, curriculum vitae, clinical
protocol, and financial disclosure ...................................
312.54(a), Sponsor submissions to FDA concerning investigations involving an exception from informed consent under § 50.24 ..........................................................
312.54(b), Sponsor notifications to FDA and others concerning an 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 brochures submitted
by the sponsor to each investigator ...............................
312.55(b), Number of sponsor reports to investigators on
new observations, especially adverse reactions and
safe use ..........................................................................
312.56(b), (c), and (d), 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 ....................
312.58(a), Number of sponsor’s submissions of clinical
investigation records to FDA on request during FDA inspections ........................................................................
312.64, Number of investigator reports to the sponsor, including progress reports, safety reports, final reports,
and financial disclosure reports .....................................
312.70, During the 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 of written certifications
and written statements submitted to FDA relating to
the export of an investigational drug ..............................
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Number of
responses per
respondent
Number of
respondents
21 CFR section
PO 00000
Frm 00067
Average
burden per
response
Total annual
responses
Total hours
217
20
2
335
694
77
161
745
134
1.18
1.50
1
1.35
5.84
2.43
8.83
2.14
1.69
255
30
2
452
4,050
187
1,421
1,595
227
24
48
24
1,600
284
100
32
360
28
6,120
1,440
48
723,200
1,150,200
18,700
45,472
574,200
6,356
67
1.30
87
284
24,708
34
1.15
39
16
624
55
1.38
76
12
912
88
1.75
154
160
24,640
453
6.33
2,869
80
229,520
1
1
1
48
48
1
1
1
48
48
239
1.91
457
48
21,936
243
4.95
1,203
48
57,744
108
2.21
239
80
19,120
7
8
56
10,411
24
249,864
7
2,728
1
3.82
5
5
40
200
18
Fmt 4703
1
1
18
75
1,350
Sfmt 4703
E:\FR\FM\03MRN1.SGM
03MRN1
11454
Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS 1—Continued
312.120(b), Number of submissions to FDA of ‘‘supporting information’’ related to the use of foreign clinical studies not conducted under an IND .......................
312.120(c), Number of waiver requests submitted to FDA
related to the use of foreign clinical studies not conducted under an IND ......................................................
312.130, Number of requests for disclosable information
in an IND and for investigations involving an exception
from informed consent under § 50.24 ............................
312.310(b) and 312.305(b), Number of submissions related to expanded access and treatment of an individual patient ..................................................................
312.310(d), Number of submissions related to emergency use of an investigational new drug .....................
312.315(c) and 312.305(b), Number of submissions related to expanded access and treatment of an intermediate-size patient population .....................................
312.320(b), Number of submissions related to a treatment IND or treatment protocol .....................................
Total ............................................................................
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section
Average
burden per
response
Total annual
responses
Total hours
280
9.82
2,750
32
88,000
7
2.29
16
24
384
350
1.34
470
8
3,760
78
1.08
84
8
672
76
2.76
210
16
3,360
9
1
9
120
1,080
1
1
1
300
300
........................
........................
3,254,062
........................
..........................
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS 1
Number of
recordkeepers
21 CFR section
312.52(a), Sponsor records for the transfer of obligations
to a contract research organization ...............................
312.57, Sponsor recordkeeping showing the receipt,
shipment, or other disposition of the investigational
drug, and any financial interests ....................................
312.62(a), Investigator recordkeeping of the disposition
of drugs ..........................................................................
312.62(b), Investigator recordkeeping of case histories of
individuals .......................................................................
312.160(a)(3), Records pertaining to the shipment of
drugs for investigational use in laboratory research animals or in vitro tests .......................................................
312.160(c), Shipper records of alternative disposition of
unused drugs ..................................................................
Total ............................................................................
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
75
1.40
105
2
210
335
2.70
904
100
90,400
453
1
453
40
18,120
453
1
453
40
18,120
111
1.40
155
* 0.50
78
111
1.40
155
* 0.50
78
........................
..........................
........................
........................
127,006
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
* Thirty (30) minutes.
Dated: February 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–04379 Filed 3–2–15; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2015–N–0430]
BILLING CODE 4164–01–P
mstockstill on DSK4VPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Measuring Dystrophin in
Dystrophinopathy Patients and
Interpreting the Data; Public Scientific
Workshop; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public scientific
workshop; request for comments.
ACTION:
The Food and Drug Administration
(FDA) is announcing a public scientific
VerDate Sep<11>2014
19:24 Mar 02, 2015
Jkt 235001
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
workshop to discuss dystrophin protein
quantification methodologies for human
tissue. This workshop is being
cosponsored by the National Institutes
of Health (NIH). The purpose of the
workshop is to discuss currently
available methodologies and to identify
scientific knowledge gaps and
opportunities for improving dystrophin
protein detection in the context of drug
development. The intended audiences
for this workshop are scientists and
clinicians involved in the acquisition,
measurement, and analysis of proteins
associated with Duchenne Muscular
Dystrophy (DMD).
E:\FR\FM\03MRN1.SGM
03MRN1
Agencies
[Federal Register Volume 80, Number 41 (Tuesday, March 3, 2015)]
[Notices]
[Pages 11449-11454]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-04379]
-----------------------------------------------------------------------
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 Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by April
2, 2015.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0014.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Investigational New Drug (IND) Regulations--21 CFR Part 312 (OMB
Control Number 0910-0014)--Extension
FDA is requesting OMB approval for the reporting and recordkeeping
requirements contained in FDA regulations entitled ``Investigational
New Drug Application'' in part 312 (21 CFR part 312). Part 312
implements provisions of section 505(i) of the Federal Food, Drug, and
Cosmetic Act (the 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 drug
products marketed in the United States be shown to be safe and
effective, properly manufactured, and properly labeled for their
intended uses. Section 505(a) of the FD&C Act 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 IND regulations 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.
Submissions are reviewed by medical officers and other Agency
scientific reviewers assigned responsibility for overseeing the
specific study. The IND regulations also contain recordkeeping
requirements that pertain to the responsibilities of sponsors and
investigators. The detail 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 which must be conducted prior to authorizing the sale
and general use of new drugs. These reports enable FDA to monitor a
study's
[[Page 11450]]
progress, to assure subject safety, to assure 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.
There are two forms that are required under part 312:
Form FDA-1571--``Investigational New Drug Application.'' A person
who intends to conduct a clinical investigation submits this form to
FDA. It includes the following information:
(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--``Investigator Statement.'' Before permitting an
investigator to begin participation in an investigation, the sponsor
must obtain and record this form. It includes background information on
the investigator and the investigation, and a general outline of the
planned investigation and the study protocol.
FDA is requesting OMB approval for the following reporting and
recordkeeping requirements in part 312.
I. Reporting Requirements
Section 312.2(e)--Requests for FDA advice on the applicability of part
312 to a planned clinical investigation.
Section 312.6--Labeling of an investigational new drug. Estimates for
the information collection in this requirement are included under Sec.
312.23(a)(7)(iv)(d).
Section 312.8--Charging for investigational drugs under an IND.
Section 312.10--Applications for waiver of requirements under part 312.
As indicated in Sec. 312.10(a), estimates for the information
collection in this requirement are included under Sec. Sec. 312.23 and
312.31. In addition, other waiver requests under Sec. 312.10 are
estimated in table 1.
Section 312.20(c)--Applications for investigations involving an
exception from informed consent under Sec. 50.24 (21 CFR 50.24).
Estimates for the information collection in this requirement are
included under Sec. 312.23.
Section 312.23--IND (content and format).
Section 312.23(a)(1)--Cover sheet FDA-1571.
Section 312.23(a)(2)--Table of Contents.
Section 312.23(a)(3)--Investigational plan for each planned study.
Section 312.23(a)(5)--Investigator's brochure.
Section 312.23(a)(6)--Protocols--Phase 1, 2, and 3.
Section 312.23(a)(7)--Chemistry, manufacturing, and control
information.
Section 312.23(a)(7)(iv)(a),(b),(c)--A description of the drug
substance, a list of all components, and any placebo used.
Section 312.23(a)(7)(iv)(d)--Labeling: Copies of labels and labeling to
be provided each investigator.
Section 312.23(a)(7)(iv)(e)--Environmental impact analysis regarding
drug manufacturing and use.
Section 312.23(a)(8)--Pharmacological and toxicology information.
Section 312.23(a)(9)--Previous human experience with the
investigational drug.
Section 312.23(a)(10)--Additional information.
Section 312.23(a)(11)--Relevant information.
Section 312.23(f)--Identification of exception from informed consent.
Section 312.30--Protocol amendments.
Sec. 312.30(a)--New protocol
Sec. 312.30(b)--Changes in protocol
Sec. 312.30(c)--New investigator.
Sec. 312.30(d)--Content and format.
Sec. 312.30(e)--Frequency.
Section 312.31--Information amendments.
Sec. 312.31(b)--Content and format.
-- Chemistry, toxicology, or technical information.
Section 312.32--Safety reports.
Sec. 312.32(c)(1)--Written reports to FDA and to investigators.
Sec. 312.32(c)(2)--Telephone reports to FDA for fatal or life-
threatening experience.
Sec. 312.32(c)(3)--Format or frequency.
Sec. 312.32(d)--Followup submissions.
Section 312.33--Annual reports.
Sec. 312.33(a)--Individual study information.
Sec. 312.33(b)--Summary information.
Sec. 312.33(b)(1)--Adverse experiences.
Sec. 312.33(b)(2)--Safety report summary.
Sec. 312.33(b)(3)--List of fatalities and causes of death.
Sec. 312.33(b)(4)--List of discontinuing subjects.
Sec. 312.33 (b)(5)--Drug action.
Sec. 312.33 (b)(6)--Preclinical studies and findings.
Sec. 312.33 (b)(7)--Significant changes.
Sec. 312.33(c)--Next year general investigational plan.
Sec. 312.33(d)--Brochure revision.
Sec. 312.33(e)--Phase I protocol modifications.
Sec. 312.33(f)--Foreign marketing developments.
Section 312.38(b) and (c)--Notification of withdrawal of an IND.
Section 312.41--Comment and advice on an IND. Estimates for the
information collection in this requirement are included under Sec.
312.23.
Section 312.42--Sponsor requests that a clinical hold be removed, and
submits a complete response to the issues identified in the clinical
hold order.
Section 312.44(c) and (d)--Opportunity for sponsor response to FDA when
IND is terminated.
Section 312.45(a) and (b)--Sponsor request for, or response to, an
inactive status determination of an IND.
Section 312.47--Meetings, including ``End-of-Phase 2'' meetings and
``Pre-NDA'' meetings.
Section 312.48--Dispute resolution. Estimates for the information
collection in this requirement are included under Sec. 312.47.
Section 312.53(c)--Investigator information. Investigator report (Form
FDA-1572) and narrative; Investigator's background information; Phase 1
outline of planned investigation and Phase 2 outline of study protocol.
Section 312.54(a) and (b)--Sponsor submissions concerning
investigations involving an exception from informed consent under Sec.
50.24.
Sec. 312.55(b)--Sponsor reports to investigators on new
observations, especially adverse reactions and safe use. Only ``new
observations'' are estimated under this section; investigator brochures
are included under Sec. 312.23.
Section 312.56(b), (c), and (d)--Sponsor monitoring of all clinical
investigations, investigators, and drug safety; notification to FDA and
others.
Section 312.58(a)--Sponsor's submission of records to FDA on request.
Section 312.64--Investigator reports to the sponsor.
Sec. 312.64(a)--Progress reports.
Sec. 312.64(b)--Safety reports
Sec. 312.64(c)--Final reports.
Sec. 312.64(d)--Financial disclosure
[[Page 11451]]
reports.
Section 312.66--Investigator reports to institutional review board
(IRB). Estimates for the information collection in this requirement are
included under Sec. 312.53.
Section 312.70--Investigator disqualification; opportunity to respond
to FDA.
Section 312.83--Sponsor submission of treatment protocol. Estimates for
this requirement are included under Sec. 312.320.
Section 312.85--Sponsors conducting phase 4 studies. Estimates for the
information collection in this requirement are included under Sec.
312.23, and under Sec. Sec. 314.50, 314.70, and 314.81 in OMB control
number 0910-0001.
Section 312.110(b)--Requests to export an investigational drug.
Section 312.120--Submissions related to foreign clinical studies not
conducted under an IND.
Section 312.130--Requests for disclosable information in an IND and
from investigations involving an exception from informed consent under
Sec. 50.24.
Sections 312.310(b); 312.305(b)--Submissions related to expanded access
and treatment of an individual patient.
Section 312.310(d)--Submissions related to emergency use of an
investigational new drug.
Sections 312.315(c); 312.305(b)--Submissions related to expanded access
and treatment of an intermediate-size patient population.
Section 312.320--Submissions related to a treatment IND or treatment
protocol.
II. Recordkeeping Requirements
Section 312.52(a)--Transfer of obligations to a contract research
organization.
Section 312.57--Sponsor recordkeeping on the investigational drug.
Section 312.59--Sponsor recordkeeping of disposition of unused supply
of drugs. Estimates for the information collection in this requirement
are included under Sec. 312.57.
Section 312.62(a)--Investigator recordkeeping of disposition of drugs.
Section 312.62(b)--Investigator recordkeeping of case histories of
individuals.
Section 312.120(d)--Recordkeeping requirements for submissions related
to foreign clinical studies not conducted under an IND. Estimates for
the information collection in this requirement are included under Sec.
312.57.
Section 312.160(a)(3)--Records pertaining to the shipment of drugs for
investigational use in laboratory research animals or in vitro tests.
Section 312.160(c)--Shipper records of alternative disposition of
unused drugs.
In the Federal Register of November 5, 2014 (79 FR 65663), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received 24 comments, however, these
comments did not address the information collection.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden for Human Drugs \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 800 1 800 24 19,200
advice on the applicability of
part 312 to a planned clinical
investigation..................
312.8, Requests to charge for an 56 1.25 70 48 3,360
investigational drug...........
312.10, Requests to waive a 50 1.76 88 24 2,112
requirement in part 312........
312.23(a) through (f), IND 1,689 1.57 2,648 1,600 4,236,800
content and format (including
Form FDA 1571).................
312.30(a) through (e), Protocol 3,739 5.77 21,588 284 6,130,992
amendments.....................
312.31 (b), Information 4,537 3.39 15,377 100 1,537,700
amendments.....................
312.32(c) and (d), IND Safety 755 24.28 18,332 32 586,624
reports........................
312.33(a) through (f), IND 2,877 2.76 7,953 360 2,863,080
Annual reports.................
312.38(b) and (c), Notifications 862 1.54 1,328 28 37,184
of withdrawal of an IND........
312.42, Sponsor requests that a 158 1.30 205 284 58,220
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 12 1 12 16 192
responses to FDA when IND is
terminated.....................
312.45(a) and (b), Sponsor 260 1.73 451 12 5,412
requests for or responses to an
inactive status determination
of an IND by FDA...............
312.47, Meetings, including 225 1.86 419 160 67,040
``End-of-Phase 2'' meetings and
``Pre-NDA'' meetings...........
312.53(c), Investigator reports 1,444 8.38 12,087 80 966,960
submitted to the sponsor,
including Form FDA 1572,
curriculum vitae, clinical
protocol, and financial
disclosure. (Third party
disclosure)....................
312.54(a), Sponsor submissions 7 5 35 48 1,680
to FDA concerning
investigations involving an
exception from informed consent
under 21 CFR 50.24.............
312.54(b), Sponsor notifications 7 1 7 48 336
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).
(Includes third party
disclosure)....................
312.55(a), Investigator 590 3.50 2,067 48 99,216
brochures submitted by the
sponsor to each investigator.
(Third party disclosure).......
[[Page 11452]]
312.55(b), Sponsor reports to 590 3.50 2,067 48 99,216
investigators on new
observations, especially
adverse reactions and safe use.
(Third party disclosure).......
312.56(b),(c), and (d), Sponsor 3,584 6.52 23,355 80 1,868,400
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.
(Includes third party
disclosure)....................
312.58(a), Sponsor's submissions 60 1 60 8 480
of clinical investigation
records to FDA on request
during FDA inspections.........
312.64, Investigator reports to 1,444 1 1,444 24 34,656
the sponsor, including progress
reports, safety reports, final
reports, and financial
disclosure reports. (Third
party disclosure)..............
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...................
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........
312.120(b), Submissions to FDA 1,414 8.63 12,198 32 390,336
of ``supporting information''
related to the use of foreign
clinical studies not conducted
under an IND...................
312.120(c), Waiver requests 35 2.34 82 24 1,968
submitted to FDA related to the
use of foreign clinical studies
not conducted under an IND.....
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..........................
312.310(b) and 312.305(b), 228 1.76 401 8 3,208
Submissions related to expanded
access and treatment of an
individual patient.............
312.310(d), Submissions related 410 2.19 899 16 14,384
to emergency use of an
investigational new drug.......
312.315(c) and 312.305(b), 44 7.07 311 120 37,320
Submissions related to expanded
access and treatment of an
intermediate-size patient
population.....................
312.320(b), Submissions related 12 12.67 152 300 45,600
to a treatment IND or treatment
protocol.......................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 19,134,039
----------------------------------------------------------------------------------------------------------------
\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 \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 335 1.50 503 2 1,006
the transfer of obligations to
a contract research
organization...................
312.57, Sponsor recordkeeping 1,689 1 1,689 100 168,900
showing the receipt, shipment,
or other disposition of the
investigational drug, and any
financial interests............
312.62(a), Investigator 1,444 1 1,444 40 57,760
recordkeeping of the
disposition of drugs...........
312.62(b), Investigator 1,444 1 1,444 40 57,760
recordkeeping of case histories
of individuals.................
312.160(a)(3), Records 547 1.40 782 * 0.50 391
pertaining to the shipment of
drugs for investigational use
in laboratory research animals
or in vitro tests..............
312.160(c), Shipper records of 547 1.40 782 * 0.50 391
alternative disposition of
unused drugs...................
-------------------------------------------------------------------------------
[[Page 11453]]
Total....................... .............. .............. .............. .............. 286,190
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
* Thirty (30) minutes.
Table 3--Estimated Annual Reporting Burden for Biologics \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 217 1.18 255 24 6,120
advice 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 4,050 284 1,150,200
amendments.....................
312.31(b), Information 77 2.43 187 100 18,700
amendments.....................
312.32(c) and (d), IND Safety 161 8.83 1,421 32 45,472
reports........................
312.33(a) through (f), IND 745 2.14 1,595 360 574,200
Annual reports.................
312.38(b) and (c), Notifications 134 1.69 227 28 6,356
of withdrawal of an IND........
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 88 1.75 154 160 24,640
``End-of-Phase 2'' meetings and
``Pre-NDA'' meetings...........
312.53(c), Investigator reports 453 6.33 2,869 80 229,520
submitted to the sponsor,
including Form FDA-1572,
curriculum vitae, clinical
protocol, and financial
disclosure.....................
312.54(a), Sponsor submissions 1 1 1 48 48
to FDA concerning
investigations involving an
exception from informed consent
under Sec. 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 Sec. 50.24(a).....
312.55(a), Number of 239 1.91 457 48 21,936
investigator 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 10,411 24 249,864
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........
[[Page 11454]]
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...................
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 1.34 470 8 3,760
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), 78 1.08 84 8 672
Number of submissions related
to expanded access and
treatment of an individual
patient........................
312.310(d), Number of 76 2.76 210 16 3,360
submissions related to
emergency use of an
investigational new drug.......
312.315(c) and 312.305(b), 9 1 9 120 1,080
Number of submissions related
to expanded access and
treatment of an intermediate-
size patient population........
312.320(b), Number of 1 1 1 300 300
submissions related to a
treatment IND or treatment
protocol.......................
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Total....................... .............. .............. .............. .............. 3,254,062
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 4--Estimated Annual Recordkeeping Burden for Biologics \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 111 1.40 155 * 0.50 78
pertaining 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 * 0.50 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.
* Thirty (30) minutes.
Dated: February 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-04379 Filed 3-2-15; 8:45 am]
BILLING CODE 4164-01-P