Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Applications, 65663-65669 [2014-26304]
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Federal Register / Vol. 79, No. 214 / Wednesday, November 5, 2014 / Notices
OMHA facilitator to discuss potential
settlement of claims with authorized
settlement officials. Additional
information on these two pilots can be
found on OMHA’s Web site, https://
www.hhs.gov/omha.
In addition to these initiatives, OMHA
continues to pursue new case
processing efficiencies and an electronic
case adjudication processing
environment (ECAPE) to bring further
efficiencies to the appeals process.
II. Request for Information
OMHA is seeking input from the
public on the current initiatives being
undertaken at the Administrative Law
Judge level, as well as suggestions for
additional initiatives which could be
undertaken at OMHA to address the
Medicare claim and entitlement appeals
workload and backlog at the
Administrative Law Judge level. Input is
sought on the following topics and
questions:
• Are there suggestions related to the
current initiatives for addressing the
increased workload and/or backlog of
appeals at the Administrative Law Judge
level that comply with current statutory
authorities and requirements?
• Are there other suggestions for
addressing the increased workload and/
or backlog of appeals at the
Administrative Law Judge level that
comply with current statutory
authorities and requirements?
• Are there any current regulations
that apply to the Administrative Law
Judge level of the Medicare claim and
entitlement appeals process that could
be revised to streamline the
adjudication process while ensuring
that parties to the appeals, as defined at
42 CFR 405.902 and 405.906, are
afforded opportunities to participate in
the process and are kept apprised of
appeals related to claims submitted by
them or on their behalf?
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(Catalog of Federal Domestic Assistance
Program No. 93.770, Medicare—Prescription
Drug Coverage; Program No. 93.773,
Medicare—Hospital Insurance; and Program
No. 93.774, Medicare—Supplementary
Medical Insurance Program)
Dated: October 30, 2014.
Nancy J. Griswold,
Chief Administrative Law Judge, Office of
Medicare Hearings and Appeals.
[FR Doc. 2014–26214 Filed 11–4–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[CFDA Number: 93.647]
Announcement of the Award of a
Single-Source Program Expansion
Supplement Grant to Child Trends,
Inc., in Bethesda, MD
Office of Planning, Research
and Evaluation, ACF, HHS.
ACTION: Announcement of the award of
a single-source expansion supplement
grant to Child Trends, Inc., in Bethesda,
MD, to support activities that promote
the economic and social well-being of
individuals, families, and communities.
AGENCY:
The Administration for
Children and Families (ACF), Office of
Planning, Research and Evaluation
(OPRE) announces the award of a singlesource expansion supplement award in
the amount of $120,000 to Child Trends,
Inc., in Bethesda, MD, to support
activities that will provide researchbased information to improve
understanding of how to promote the
economic and social well-being of
underserved and under-represented
populations.
DATES: September 30, 2014 through
September 29, 2015.
FOR FURTHER INFORMATION CONTACT: Ann
Rivera, Social Science Research Analyst,
Office of Planning, Research &
Evaluation, Administration for Children
and Families, 370 L’Enfant Promenade
SW., Washington, DC 20447; Telephone:
(202) 401–5506; Email: ann.rivera@
acf.hhs.gov.
SUPPLEMENTARY INFORMATION: Under this
grant program, Child Trends, Inc., a
non-profit, nonpartisan research center,
has established the National Research
Center on Hispanic Children and
Families, which brings together an
interdisciplinary team of academic and
organizational partners to provide
leadership in culturally competent
research that can inform policies
concerning low-income Hispanic
families and to foster significant
scholarship regarding the needs and
experiences of the Hispanic populations
throughout the nation. This ACFsponsored research center develops
research products and research-based
resources that aim to build research
capacity in the field and to improve
understanding of Hispanic populations
in order to inform policy development
and programmatic responses.
The award of a single-source
expansion supplement to this research
SUMMARY:
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65663
center will support activities to develop
research-based resources to inform ACF
program offices, current and future ACF
grantees, and potential ACF grant
applicants about the characteristics and
needs of underserved and underrepresented populations.
Statutory Authority: Section 1110 of the
Social Security Act (42 U.S.C. 1310).
Melody Wayland,
Senior Grants Policy Specialist, Office of
Administration, Office of Financial Services/
Division of Grants Policy.
[FR Doc. 2014–26226 Filed 11–4–14; 8:45 am]
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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.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
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 January 5, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA 305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
SUMMARY:
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and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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.
SUPPLEMENTARY INFORMATION:
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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 21 CFR part
312 (part 312). Part 312 implements
provisions of section 505(i) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(i)) (the FD&C Act) 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
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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; (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
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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
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
21 CFR 312.2(e)—Requests for FDA
advice on the applicability of part 312
to a planned clinical investigation.
21 CFR 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).
21 CFR 312.8—Charging for
investigational drugs under an IND.
21 CFR 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.
21 CFR 312.20(c)—Applications for
investigations involving an exception
from informed consent under § 50.24
(21 CFR 50.24). Estimates for the
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information collection in this
requirement are included under
§ 312.23.
21 CFR 312.23—IND (content and
format).
.23(a)(1)—Cover sheet FDA–1571.
.23(a)(2)—Table of Contents.
.23(a)(3)—Investigational plan for
each planned study.
.23(a)(5)—Investigator’s brochure.
.23(a)(6)—Protocols—Phase 1, 2, and
3.
.23(a)(7)—Chemistry, manufacturing,
and control information.
.23(a)(7)(iv)(a),(b),(c)—A description
of the drug substance, a list of all
components, and any placebo used.
.23(a)(7)(iv)(d)—Labeling: Copies of
labels and labeling to be provided
each investigator.
.23(a)(7)(iv)(e)—Environmental
impact analysis regarding drug
manufacturing and use.
.23(a)(8)—Pharmacological and
toxicology information.
.23(a)(9)—Previous human experience
with the investigational drug.
.23(a)(10)—Additional information.
.23(a)(11)—Relevant information.
.23(f)—Identification of exception
from informed consent.
21 CFR 312.30—Protocol amendments.
.30(a)—New protocol
.30(b)—Changes in protocol
.30(c)—New investigator.
.30(d)—Content and format.
.30(e)—Frequency.
21 CFR 312.31—Information
amendments.
.31(b)—Content and format.
—Chemistry, toxicology, or technical
information.
21 CFR 312.32—Safety reports.
.32(c)(1)—Written reports to FDA and
to investigators.
.32(c)(2)—Telephone reports to FDA
for fatal or life-threatening
experience.
.32(c)(3)—Format or frequency.
.32(d)—Followup submissions.
21 CFR 312.33—Annual reports.
.33(a)—Individual study information.
.33(b)—Summary information.
(b)(1)—Adverse experiences.
(b)(2)—Safety report summary.
(b)(3)—List of fatalities and causes of
death.
(b)(4)—List of discontinuing subjects.
(b)(5)—Drug action.
(b)(6)—Preclinical studies and
findings.
(b)(7)—Significant changes.
.33(c)—Next year general
investigational plan.
.33(d)—Brochure revision.
.33(e)—Phase I protocol
modifications.
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.33(f)—Foreign marketing
developments.
21 CFR 312.38(b) and (c)—Notification
of withdrawal of an IND.
21 CFR 312.41—Comment and advice
on an IND. Estimates for the
information collection in this
requirement are included under
§ 312.23.
21 CFR 312.42—Sponsor requests that a
clinical hold be removed, and submits
a complete response to the issues
identified in the clinical hold order.
21 CFR 312.44(c) and (d)—Opportunity
for sponsor response to FDA when
IND is terminated.
21 CFR 312.45(a) and (b)—Sponsor
request for, or response to, an inactive
status determination of an IND.
21 CFR 312.47—Meetings, including
‘‘End-of-Phase 2’’ meetings and ‘‘PreNDA’’ meetings.
21 CFR 312.48—Dispute resolution.
Estimates for the information
collection in this requirement are
included under § 312.47.
21 CFR 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.
21 CFR 312.54(a) and (b)—Sponsor
submissions concerning
investigations involving an exception
from informed consent under § 50.24.
21 CFR 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.
21 CFR 312.56(b), (c), and (d)—Sponsor
monitoring of all clinical
investigations, investigators, and drug
safety; notification to FDA and others.
21 CFR 312.58(a)—Sponsor’s
submission of records to FDA on
request.
21 CFR 312.64—Investigator reports to
the sponsor.
.64(a)—Progress reports.
.64(b)—Safety reports
.64(c)—Final reports.
.64(d)—Financial disclosure reports.
21 CFR 312.66—Investigator reports to
institutional review board (IRB).
Estimates for the information
collection in this requirement are
included under § 312.53.
21 CFR 312.70—Investigator
disqualification; opportunity to
respond to FDA.
21 CFR 312.83—Sponsor submission of
treatment protocol. Estimates for this
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65665
requirement are included under
§ 312.320.
21 CFR 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.
21 CFR 312.110(b)—Requests to export
an investigational drug.
21 CFR 312.120—Submissions related to
foreign clinical studies not conducted
under an IND.
21 CFR 312.130—Requests for
disclosable information in an IND and
from investigations involving an
exception from informed consent
under § 50.24.
21 CFR 312.310(b); 312.305(b)—
Submissions related to expanded
access and treatment of an individual
patient.
21 CFR 312.310(d)—Submissions
related to emergency use of an
investigational new drug.
21 CFR 312.315(c); 312.305(b)—
Submissions related to expanded
access and treatment of an
intermediate-size patient population.
21 CFR 312.320—Submissions related to
a treatment IND or treatment protocol.
II. Recordkeeping Requirements
21 CFR 312.52(a)—Transfer of
obligations to a contract research
organization.
21 CFR 312.57—Sponsor recordkeeping
on the investigational drug.
21 CFR 312.59—Sponsor recordkeeping
of disposition of unused supply of
drugs. Estimates for the information
collection in this requirement are
included under § 312.57.
21 CFR 312.62(a)—Investigator
recordkeeping of disposition of drugs.
21 CFR 312.62(b)—Investigator
recordkeeping of case histories of
individuals.
21 CFR 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.
21 CFR 312.160(a)(3)—Records
pertaining to the shipment of drugs
for investigational use in laboratory
research animals or in vitro tests.
21 CFR 312.160(c)—Shipper records of
alternative disposition of unused
drugs.
FDA estimates the burden of this
collection of information as follows:
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1
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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) ..........
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 .......................................
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Number of
responses per
respondent
Number of
respondents
21 CFR Section
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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
590
3.50
2,067
48
99,216
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
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1
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1—Continued
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 ..........................................................
Average
burden per
response
Total annual
responses
Total hours
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
........................
Total ............................................................................
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR Section
..........................
........................
........................
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 DRUGS1
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 .................................................
1 There
Number of records
per recordkeeper
335
Average burden
per recordkeeping
Total annual
records
1.50
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 (30 minutes).
391
547
1.40
782
0.50 (30 minutes).
391
..............................
................................
..............................
...........................
286,190
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS1
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 ...................................
VerDate Sep<11>2014
17:42 Nov 04, 2014
Jkt 235001
Number of
responses per
respondent
Number of
respondents
21 CFR section
PO 00000
Frm 00053
Total annual
responses
Average
burden per
response
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
Fmt 4703
Sfmt 4703
E:\FR\FM\05NON1.SGM
05NON1
65668
Federal Register / Vol. 79, No. 214 / Wednesday, November 5, 2014 / Notices
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS1—Continued
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 ..............................
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 .....................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Average
burden per
response
Total annual
responses
Total hours
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
1
2,728
3.82
5
1
5
40
200
18
1
18
75
1,350
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
Total ............................................................................
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section
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 BIOLOGICS1
Number of
recordkeepers
21 CFR Section
312.52(a), Sponsor records for the
transfer of obligations to a contract research organization.
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17:42 Nov 04, 2014
Jkt 235001
Number of records
per recordkeeper
75
PO 00000
Frm 00054
1.40
Fmt 4703
Sfmt 4703
Total annual
records
105
E:\FR\FM\05NON1.SGM
Average burden
per recordkeeping
2 .......................
05NON1
Total hours
210
Federal Register / Vol. 79, No. 214 / Wednesday, November 5, 2014 / Notices
65669
TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS1—Continued
Number of
recordkeepers
21 CFR Section
Number of records
per recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
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.
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 (30 minutes).
78
111
1.40
155
0.50 (30 minutes).
78
Total .................................................
..............................
................................
..............................
1 There
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1119]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food Canning
Establishment Registration, Process
Filing, and Recordkeeping for Acidified
Foods and Thermally Processed LowAcid Foods in Hermetically Sealed
Containers; Correction
Food and Drug Administration,
HHS.
Notice; correction.
The Food and Drug
Administration (FDA or we) is
correcting a notice that appeared in the
Federal Register of August 14, 2014.
The notice announced that a proposed
collection of information had been
submitted to the Office of Management
and Budget (OMB) for review and
clearance under the Paperwork
Reduction Act of 1995. In this
document, we correct some errors that
appeared in the notice.
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.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:42 Nov 04, 2014
Jkt 235001
In FR Doc.
2014–19241, appearing on page 47642
in the Federal Register of August 14,
2014 (79 FR 47642), we make the
following corrections:
1. On page 47643, in the second
column, in the Response to Comment 3,
delete the sentence starting with ‘‘The
scope of the voluntary submission . . .
and the product label.’’
2. On page 47643, in the second
column, in the Response to Comment 3,
in the sentence starting with
‘‘Consequently, we have proposed
. . .,’’ delete ‘‘institute the voluntary
consultation process discussed in this
document’’ and replace it with ‘‘provide
for the voluntary registration and Form
FDA 2541e submission process’’.
3. On page 47643, in the second and
third columns, in the Response to
Comment 3, delete the sentences
starting with ‘‘The ability to submit a
voluntary submission . . . of part 114’’
and the remaining sentences in the
response and replace them with ‘‘FDA
has authority to implement the
voluntary submission process under
sections 402 and 404 of the FD&C Act.’’
4. On page 47643, in the third
column, in the Response to Comment 4,
replace the response with the following:
‘‘A voluntary process filing submission
will not result in part 114 applying to
products that are not acidified foods as
defined in 21 CFR 114.3(b). Further, the
voluntary process filing submission
process will not result in any changes to
part 114.’’
5. On pages 47643 to 47644, in the
third column on page 47643 and in the
first column on page 47644, in the
Response to Comment 5, replace the
response with the following: ‘‘Our
inspectors will not expect all
SUPPLEMENTARY INFORMATION:
[FR Doc. 2014–26304 Filed 11–4–14; 8:45 am]
ACTION:
127,006
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
AGENCY:
...........................
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
manufacturers to submit voluntary
submissions.’’
6. On page 47644, in the first column,
in the Response to Comment 7, replace
the response with the following: ‘‘As
discussed in the response to Comment
4, if a product is not an acidified food,
the product is not subject to the good
manufacturing practice requirements in
part 114 and will not become subject to
those regulations as a result of a
voluntary submission.’’
7. On page 47644, in the first and
second columns, in the Response to
Comment 8, replace the response with
the following: ‘‘The draft guidance did
address the issue of what constitutes a
fermented food. We expect that the
acidified foods guidance, when
finalized, will provide guidance on
what constitutes a fermented food.’’
8. On page 47644, in the second
column, in the Response to Comment 9,
replace the response with the following:
‘‘Manufacturers are free to decide
whether to make a voluntary
submission, and we believe that some
manufacturers may choose to do so. For
FDA, the voluntary submission results
in increased efficiency.’’
9. On page 47644, in the second and
third columns, in the Response to
Comment 10, delete the first paragraph
of the response and delete the second
sentence in the second paragraph of the
response.
10. On page 47645, in the first
column, in the Response to Comment
13, in the second sentence in the second
paragraph of the response, delete ‘‘to
prevent the detention of product’’.
11. On page 47645, in the third
column, in the Response to Comment
20, in the first sentence of the response,
replace ‘‘and provides’’ with ‘‘and,
when finalized, will provide’’.
E:\FR\FM\05NON1.SGM
05NON1
]]>Agencies
[Federal Register Volume 79, Number 214 (Wednesday, November 5, 2014)]
[Notices]
[Pages 65663-65669]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26304]
-----------------------------------------------------------------------
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) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 January 5, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food
[[Page 65664]]
and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
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 (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 21 CFR part 312 (part 312). Part 312
implements provisions of section 505(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(i)) (the FD&C Act) 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; (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 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
21 CFR 312.2(e)--Requests for FDA advice on the applicability of part
312 to a planned clinical investigation.
21 CFR 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).
21 CFR 312.8--Charging for investigational drugs under an IND.
21 CFR 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.
21 CFR 312.20(c)--Applications for investigations involving an
exception from informed consent under Sec. 50.24 (21 CFR 50.24).
Estimates for the
[[Page 65665]]
information collection in this requirement are included under Sec.
312.23.
21 CFR 312.23--IND (content and format).
.23(a)(1)--Cover sheet FDA-1571.
.23(a)(2)--Table of Contents.
.23(a)(3)--Investigational plan for each planned study.
.23(a)(5)--Investigator's brochure.
.23(a)(6)--Protocols--Phase 1, 2, and 3.
.23(a)(7)--Chemistry, manufacturing, and control information.
.23(a)(7)(iv)(a),(b),(c)--A description of the drug substance, a
list of all components, and any placebo used.
.23(a)(7)(iv)(d)--Labeling: Copies of labels and labeling to be
provided each investigator.
.23(a)(7)(iv)(e)--Environmental impact analysis regarding drug
manufacturing and use.
.23(a)(8)--Pharmacological and toxicology information.
.23(a)(9)--Previous human experience with the investigational drug.
.23(a)(10)--Additional information.
.23(a)(11)--Relevant information.
.23(f)--Identification of exception from informed consent.
21 CFR 312.30--Protocol amendments.
.30(a)--New protocol
.30(b)--Changes in protocol
.30(c)--New investigator.
.30(d)--Content and format.
.30(e)--Frequency.
21 CFR 312.31--Information amendments.
.31(b)--Content and format.
--Chemistry, toxicology, or technical information.
21 CFR 312.32--Safety reports.
.32(c)(1)--Written reports to FDA and to investigators.
.32(c)(2)--Telephone reports to FDA for fatal or life-threatening
experience.
.32(c)(3)--Format or frequency.
.32(d)--Followup submissions.
21 CFR 312.33--Annual reports.
.33(a)--Individual study information.
.33(b)--Summary information.
(b)(1)--Adverse experiences.
(b)(2)--Safety report summary.
(b)(3)--List of fatalities and causes of death.
(b)(4)--List of discontinuing subjects.
(b)(5)--Drug action.
(b)(6)--Preclinical studies and findings.
(b)(7)--Significant changes.
.33(c)--Next year general investigational plan.
.33(d)--Brochure revision.
.33(e)--Phase I protocol modifications.
.33(f)--Foreign marketing developments.
21 CFR 312.38(b) and (c)--Notification of withdrawal of an IND.
21 CFR 312.41--Comment and advice on an IND. Estimates for the
information collection in this requirement are included under Sec.
312.23.
21 CFR 312.42--Sponsor requests that a clinical hold be removed, and
submits a complete response to the issues identified in the clinical
hold order.
21 CFR 312.44(c) and (d)--Opportunity for sponsor response to FDA when
IND is terminated.
21 CFR 312.45(a) and (b)--Sponsor request for, or response to, an
inactive status determination of an IND.
21 CFR 312.47--Meetings, including ``End-of-Phase 2'' meetings and
``Pre-NDA'' meetings.
21 CFR 312.48--Dispute resolution. Estimates for the information
collection in this requirement are included under Sec. 312.47.
21 CFR 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.
21 CFR 312.54(a) and (b)--Sponsor submissions concerning investigations
involving an exception from informed consent under Sec. 50.24.
21 CFR 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.
21 CFR 312.56(b), (c), and (d)--Sponsor monitoring of all clinical
investigations, investigators, and drug safety; notification to FDA and
others.
21 CFR 312.58(a)--Sponsor's submission of records to FDA on request.
21 CFR 312.64--Investigator reports to the sponsor.
.64(a)--Progress reports.
.64(b)--Safety reports
.64(c)--Final reports.
.64(d)--Financial disclosure reports.
21 CFR 312.66--Investigator reports to institutional review board
(IRB). Estimates for the information collection in this requirement are
included under Sec. 312.53.
21 CFR 312.70--Investigator disqualification; opportunity to respond to
FDA.
21 CFR 312.83--Sponsor submission of treatment protocol. Estimates for
this requirement are included under Sec. 312.320.
21 CFR 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.
21 CFR 312.110(b)--Requests to export an investigational drug.
21 CFR 312.120--Submissions related to foreign clinical studies not
conducted under an IND.
21 CFR 312.130--Requests for disclosable information in an IND and from
investigations involving an exception from informed consent under Sec.
50.24.
21 CFR 312.310(b); 312.305(b)--Submissions related to expanded access
and treatment of an individual patient.
21 CFR 312.310(d)--Submissions related to emergency use of an
investigational new drug.
21 CFR 312.315(c); 312.305(b)--Submissions related to expanded access
and treatment of an intermediate-size patient population.
21 CFR 312.320--Submissions related to a treatment IND or treatment
protocol.
II. Recordkeeping Requirements
21 CFR 312.52(a)--Transfer of obligations to a contract research
organization.
21 CFR 312.57--Sponsor recordkeeping on the investigational drug.
21 CFR 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.
21 CFR 312.62(a)--Investigator recordkeeping of disposition of drugs.
21 CFR 312.62(b)--Investigator recordkeeping of case histories of
individuals.
21 CFR 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.
21 CFR 312.160(a)(3)--Records pertaining to the shipment of drugs for
investigational use in laboratory research animals or in vitro tests.
21 CFR 312.160(c)--Shipper records of alternative disposition of unused
drugs.
FDA estimates the burden of this collection of information as
follows:
[[Page 65666]]
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).......
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..........................
[[Page 65667]]
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 Number of records Total annual
21 CFR Section recordkeepers per recordkeeper records Average burden per recordkeeping Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
312.52(a), Sponsor records for the 335 1.50 503 2............................... 1,006
transfer of obligations to a contract
research organization.
312.57, Sponsor recordkeeping showing the 1,689 1 1,689 100............................. 168,900
receipt, shipment, or other disposition
of the investigational drug, and any
financial interests.
312.62(a), Investigator recordkeeping of 1,444 1 1,444 40.............................. 57,760
the disposition of drugs.
312.62(b), Investigator recordkeeping of 1,444 1 1,444 40.............................. 57,760
case histories of individuals.
312.160(a)(3), Records pertaining to the 547 1.40 782 0.50 (30 minutes)............... 391
shipment of drugs for investigational
use in laboratory research animals or in
vitro tests.
312.160(c) Shipper records of alternative 547 1.40 782 0.50 (30 minutes)............... 391
disposition of unused drugs.
--------------------------------------------------------------------------------------------------------------
Total................................ ................. .................. ................. ................................ 286,190
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 3--Estimated Annual Reporting Burden for Biologics\1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses 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.....................
[[Page 65668]]
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........
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.......................
-------------------------------------------------------------------------------
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 Number of records Total annual
21 CFR Section recordkeepers per recordkeeper records Average burden per recordkeeping Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
312.52(a), Sponsor records for the 75 1.40 105 2............................... 210
transfer of obligations to a contract
research organization.
[[Page 65669]]
312.57, Sponsor recordkeeping showing the 335 2.70 904 100............................. 90,400
receipt, shipment, or other disposition
of the investigational drug, and any
financial interests.
312.62(a), Investigator recordkeeping of 453 1 453 40.............................. 18,120
the disposition of drugs.
312.62(b), Investigator recordkeeping of 453 1 453 40.............................. 18,120
case histories of individuals.
312.160(a)(3), Records pertaining to the 111 1.40 155 0.50 (30 minutes)............... 78
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 (30 minutes)............... 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.
Dated: October 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26304 Filed 11-4-14; 8:45 am]
BILLING CODE 4164-01-P
