Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Applications, 50102-50107 [2018-21610]
Download as PDF
<![CDATA[
50102
Federal Register / Vol. 83, No. 193 / Thursday, October 4, 2018 / Notices
This payment is an add-on to the set
amount per case the Centers for
Medicare and Medicaid Services (CMS)
pays to hospitals under the Medicare
Inpatient Prospective Payment System
(IPPS). Under current regulations at 42
CFR 412.106, in order to meet the
qualifying criteria for this additional
DSH payment, a hospital must prove
that a disproportionate percentage of its
patients are low income using
Supplemental Security Income (SSI)
and Medicaid as proxies for this
determination. This percentage includes
two computations: (1) The ‘‘Medicare
fraction’’ or the ‘‘SSI ratio’’ which is the
percent of patient days for beneficiaries
who are eligible for Medicare Part A and
SSI and (2) the ‘‘Medicaid fraction’’
which is the percent of patient days for
patients who are eligible for Medicaid
but not Medicare. Once a hospital
qualifies for this DSH payment, CMS
also determines a hospital’s payment
adjustment based on these two fractions.
42 CFR 412.106 allows hospitals to
request that the Medicare fraction of the
DSH adjustment be calculated on a cost
reporting basis rather than a federal
fiscal year. Once requested, the hospital
must accept the result irrespective of
whether it increases or decreases their
DSH payment. The routine use
procedure and the DUA allows hospitals
to request the detailed Medicare data so
they can make an informed choice
before deciding whether to request that
the Medicare fraction be calculated on
the basis of a cost reporting period
rather than a federal fiscal year. Form
Number: CMS–R–194 (OMB control
number 0938–0691); Frequency: Yearly;
Affected Public: Private sector (Business
or other for-profits); Number of
Respondents: 800; Total Annual
Responses: 800; Total Annual Hours:
400. (For policy questions regarding this
collection contact Emily Lipkin at 410–
786–3633.)
Dated: September 28, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–21590 Filed 10–3–18; 8:45 am]
daltland on DSKBBV9HB2PROD with NOTICES
BILLING CODE 4120–01–P
VerDate Sep<11>2014
17:43 Oct 03, 2018
Jkt 247001
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, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on regulations under
which the clinical investigation of the
safety and effectiveness of unapproved
new drugs and biological products can
be conducted.
DATES: Submit either electronic or
written comments on the collection of
information by December 3, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before December 3,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 3, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2014–N–1721 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Investigational New Drug
Applications.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
E:\FR\FM\04OCN1.SGM
04OCN1
daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 193 / Thursday, October 4, 2018 / Notices
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, 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
VerDate Sep<11>2014
17:43 Oct 03, 2018
Jkt 247001
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Investigational New Drug
Application—21 CFR Part 312
OMB Control Number 0910–0014—
Extension
This information collection supports
FDA regulations in 21 CFR part 312
covering Investigational New Drugs.
Part 312 implements provisions of
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(i)) to issue regulations under which
the clinical investigation of the safety
and effectiveness of unapproved new
drugs and biological products can be
conducted.
FDA is charged with implementing
statutory requirements that ensure drug
products marketed in the United States
are shown to be safe and effective,
properly manufactured, and properly
labeled for their intended uses. Section
505(a) of the FD&C Act (21 U.S.C.
355(a)) provides that a new drug may
not be introduced or delivered for
introduction into interstate commerce in
the United States unless FDA has
previously approved a new drug
application (NDA). FDA approves an
NDA only if the sponsor of the
application first demonstrates that the
drug is safe and effective for the
conditions prescribed, recommended, or
suggested in the product’s labeling.
Proof must consist, in part, of adequate
and well-controlled studies, including
studies in humans, that are conducted
by qualified experts.
The investigational new drug
application (IND) regulations under 21
CFR part 312 establish reporting
requirements that include an initial
application as well as amendments to
that application, reports on significant
revisions of clinical investigation plans,
and information on a drug’s safety or
effectiveness. In addition, the sponsor is
required to give FDA an annual
summary of the previous year’s clinical
experience. The regulations also include
recordkeeping requirements pertaining
to the disposition of drugs, records
pertaining to individual case histories,
and certain other documentation
verifying the fulfillment of
responsibilities by clinical investigators.
Submissions are reviewed by medical
officers and other Agency scientific
reviewers assigned responsibility for
overseeing a specific study. The details
and complexity of these requirements
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
50103
are dictated by the scientific procedures
and human subject safeguards that must
be followed in the clinical tests of
investigational new drugs.
The IND information collection
requirements provide the means by
which FDA can monitor the clinical
investigation of the safety and
effectiveness of unapproved new drugs
and biological products, including the
following: (1) Monitor the safety of
ongoing clinical investigations; (2)
determine whether the clinical testing of
a drug should be authorized; (3) ensure
production of reliable data on the
metabolism and pharmacological action
of the drug in humans; (4) obtain timely
information on adverse reactions to the
drug; (5) obtain information on side
effects associated with increasing doses;
(6) obtain information on the drug’s
effectiveness; (7) ensure the design of
well-controlled, scientifically valid
studies; and (8) obtain other information
pertinent to determining whether
clinical testing should be continued and
information related to the protection of
human subjects. Without the
information provided by industry as
required under the IND regulations,
FDA cannot authorize or monitor the
clinical investigations that must be
conducted before authorizing the sale
and general use of new drugs. These
reports enable FDA to monitor a study’s
progress, to ensure the safety of subjects,
to ensure that a study will be conducted
ethically, and to increase the likelihood
that the sponsor will conduct studies
that will be useful in determining
whether the drug should be marketed
and available for use in medical
practice.
To assist respondents with certain
reporting requirements under part 312,
we have developed two forms: Form
FDA 1571 entitled, ‘‘Investigational
New Drug Application (IND)’’ and Form
FDA 1572 entitled, ‘‘Statement of
Investigator.’’ Anyone who intends to
conduct a clinical investigation must
submit Form FDA 1571 as instructed.
The reporting elements include: (1) A
cover sheet containing background
information on the sponsor and
investigator; (2) a table of contents; (3)
an introductory statement and general
investigational plan; (4) an investigator’s
brochure describing the drug substance;
(5) a protocol for each planned study;
(6) chemistry, manufacturing, and
control information for each
investigation; (7) pharmacology and
toxicology information for each
investigation; and (8) previous human
experience with the investigational
drug. Form FDA 1572 is executed and
submitted by the IND sponsor before an
investigator may participate in an
E:\FR\FM\04OCN1.SGM
04OCN1
50104
Federal Register / Vol. 83, No. 193 / Thursday, October 4, 2018 / Notices
investigation. It includes background
information on the investigator as well
as the investigation, and a general
outline of the planned investigation and
study protocol.
Below, we estimate the burden of the
information collection as reported by
FDA’s Center for Drug Evaluation and
Research (CDER) and Center for
Biologics Evaluation and Research
(CBER) as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS (CDER) 1
daltland on DSKBBV9HB2PROD 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 .................................................
§ 312.54(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) ...................
§ 312.56(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); Sponsor’s submissions of clinical investigation
records to FDA on request during FDA inspections ........
§ 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 ............................................................
VerDate Sep<11>2014
17:43 Oct 03, 2018
Jkt 247001
Number of
responses per
respondent
Number of
respondents
21 CFR section
PO 00000
Frm 00042
Total
annual
responses
Average
burden per
response
Total hours
400
74
86
1
1.23
1.84
400
91
158
24
48
24
9,600
4,368
3,792
2,187
4,418
6,691
867
3,376
930
1.7
5.52
3.32
15.78
2.86
1.61
3,718
24,387
22,214
13,681
9,655
1,497
1,600
284
100
32
360
28
5,948,800
6,925,908
2,221,400
437,792
3,475,800
41,916
198
1.38
273
284
77,532
12
1.16
14
16
224
231
1.84
425
12
5,100
122
1.51
184
160
29,440
15
2.4
36
48
1,728
2
1
2
48
96
6,100
7
42,700
80
3,416,000
73
1
73
8
584
4
1
4
40
160
11
26.28
289
75
21,675
1,414
8.62
12,189
32
390,048
35
2.34
82
24
1,968
3
1
3
8
24
935
2.77
2,590
8
20,720
480
2.15
1,032
16
16,512
118
2.52
297
120
35,640
10
12.9
129
300
38,700
Fmt 4703
Sfmt 4703
E:\FR\FM\04OCN1.SGM
04OCN1
50105
Federal Register / Vol. 83, No. 193 / Thursday, October 4, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS (CDER) 1—Continued
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
........................
........................
........................
........................
21 CFR section
Total ..............................................................................
1 There
Total hours
23,125,527
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR HUMAN DRUGS (CDER) 1
Number of
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
1,300
1
1,300
2
2,600
13,000
1
13,000
100
1,300,000
13,000
1
13,000
40
520,000
13,000
1
13,000
40
520,000
547
1.43
782
* 0.50
391
547
1.43
782
* 0.50
391
........................
........................
........................
........................
2,343,382
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
* 30 minutes.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN FOR HUMAN DRUGS (CDER) 1
Number of
respondents
21 CFR section
§ 312.53(c); Investigator reports submitted to the sponsor,
including Form FDA 1572, curriculum vitae, clinical protocol, and financial disclosure ..........................................
§ 312.55(a); Investigator brochures submitted by the sponsor to each investigator ....................................................
§ 312.55(b); Sponsor reports to investigators on new observations, especially adverse reactions and safe use ...
§ 312.64; Investigator reports to the sponsor, including
progress reports, safety reports, final reports, and financial disclosure reports ......................................................
Total ..............................................................................
1 There
Number of
disclosures
per
respondent
Total
annual
disclosures
Average
burden per
disclosure
Total hours
1,732
7.94
13,752
80
1,100,160
995
4
3,980
48
191,040
995
4
3,980
48
191,040
13,000
1
13,000
24
312,000
........................
........................
........................
........................
1,794,240
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS (CBER) 1
Number of
respondents
daltland on DSKBBV9HB2PROD with NOTICES
21 CFR section
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 .....
VerDate Sep<11>2014
17:43 Oct 03, 2018
Jkt 247001
PO 00000
Frm 00043
Number of
responses per
respondent
217
20
2
335
694
77
161
745
134
Fmt 4703
Sfmt 4703
Total
annual
responses
1.18
1.50
1
1.35
5.84
2.43
8.83
2.14
1.69
E:\FR\FM\04OCN1.SGM
256
30
2
452
4,053
187
1,422
1,594
226
04OCN1
Average
burden per
response
24
48
24
1,600
284
100
32
360
28
Total hours
6,144
1,440
48
723,200
1,151,052
18,700
45,504
573,840
6,328
50106
Federal Register / Vol. 83, No. 193 / Thursday, October 4, 2018 / Notices
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS (CBER) 1—Continued
daltland on DSKBBV9HB2PROD with NOTICES
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 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) ......................
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 intermediatesize 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
Total
annual
responses
Average
burden per
response
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
2,867
80
229,360
1
1
1
48
48
1
1
1
48
48
239
1.91
456
48
21,888
243
4.95
1,203
48
57,744
108
2.21
239
80
19,120
7
1
7
8
56
2,728
3.82
10,421
24
250,104
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
469
8
3,752
78
1.08
84
8
672
76
2.76
210
16
3,360
9
1
9
120
1,080
1
1
1
300
300
........................
........................
........................
........................
3,254,606
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Sep<11>2014
17:43 Oct 03, 2018
Jkt 247001
PO 00000
Total hours
Frm 00044
Fmt 4703
Sfmt 4703
E:\FR\FM\04OCN1.SGM
04OCN1
50107
Federal Register / Vol. 83, No. 193 / Thursday, October 4, 2018 / Notices
TABLE 5—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS (CBER) 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
* 0.5
78
111
1.40
155
* 0.5
78
........................
........................
........................
........................
127,006
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
* 30 minutes.
Because we have received an
increased number of IND submissions
since the last OMB approval of the
information collection, we have
increased our estimate of the associated
burden accordingly.
Dated: September 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–21610 Filed 10–3–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1021]
Notice to Public of Website Location of
Center for Devices and Radiological
Health Fiscal Year 2019 Proposed
Guidance Development
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing the website location where
the Agency will post two lists of
guidance documents that the Center for
Devices and Radiological Health (CDRH
or the Center) intends to publish in
fiscal year (FY) 2019. In addition, FDA
has established a docket where
interested persons may comment on the
priority of topics for guidance, provide
comments and/or propose draft
language for those topics, suggest topics
for new or different guidance
documents, comment on the
applicability of guidance documents
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:43 Oct 03, 2018
Jkt 247001
that have issued previously, and
provide any other comments that could
benefit the CDRH guidance program and
its engagement with stakeholders. This
feedback is critical to the CDRH
guidance program to ensure that we
meet stakeholder needs.
DATES: Submit either electronic or
written comments by December 3, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before December 3,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 3, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2012–N–1021 for ‘‘Notice to Public of
website Location of CDRH Fiscal Year
2019 Proposed Guidance Development.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
E:\FR\FM\04OCN1.SGM
04OCN1
]]>Agencies
[Federal Register Volume 83, Number 193 (Thursday, October 4, 2018)]
[Notices]
[Pages 50102-50107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21610]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1721]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Investigational New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on regulations under which the
clinical investigation of the safety and effectiveness of unapproved
new drugs and biological products can be conducted.
DATES: Submit either electronic or written comments on the collection
of information by December 3, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 3, 2018. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 3, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2014-N-1721 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Investigational New Drug
Applications.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this
[[Page 50103]]
information on the cover sheet and not in the body of your comments and
you must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Investigational New Drug Application--21 CFR Part 312
OMB Control Number 0910-0014--Extension
This information collection supports FDA regulations in 21 CFR part
312 covering Investigational New Drugs. Part 312 implements provisions
of section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 355(i)) to issue regulations under which the clinical
investigation of the safety and effectiveness of unapproved new drugs
and biological products can be conducted.
FDA is charged with implementing statutory requirements that ensure
drug products marketed in the United States are shown to be safe and
effective, properly manufactured, and properly labeled for their
intended uses. Section 505(a) of the FD&C Act (21 U.S.C. 355(a))
provides that a new drug may not be introduced or delivered for
introduction into interstate commerce in the United States unless FDA
has previously approved a new drug application (NDA). FDA approves an
NDA only if the sponsor of the application first demonstrates that the
drug is safe and effective for the conditions prescribed, recommended,
or suggested in the product's labeling. Proof must consist, in part, of
adequate and well-controlled studies, including studies in humans, that
are conducted by qualified experts.
The investigational new drug application (IND) regulations under 21
CFR part 312 establish reporting requirements that include an initial
application as well as amendments to that application, reports on
significant revisions of clinical investigation plans, and information
on a drug's safety or effectiveness. In addition, the sponsor is
required to give FDA an annual summary of the previous year's clinical
experience. The regulations also include recordkeeping requirements
pertaining to the disposition of drugs, records pertaining to
individual case histories, and certain other documentation verifying
the fulfillment of responsibilities by clinical investigators.
Submissions are reviewed by medical officers and other Agency
scientific reviewers assigned responsibility for overseeing a specific
study. The details and complexity of these requirements are dictated by
the scientific procedures and human subject safeguards that must be
followed in the clinical tests of investigational new drugs.
The IND information collection requirements provide the means by
which FDA can monitor the clinical investigation of the safety and
effectiveness of unapproved new drugs and biological products,
including the following: (1) Monitor the safety of ongoing clinical
investigations; (2) determine whether the clinical testing of a drug
should be authorized; (3) ensure production of reliable data on the
metabolism and pharmacological action of the drug in humans; (4) obtain
timely information on adverse reactions to the drug; (5) obtain
information on side effects associated with increasing doses; (6)
obtain information on the drug's effectiveness; (7) ensure the design
of well-controlled, scientifically valid studies; and (8) obtain other
information pertinent to determining whether clinical testing should be
continued and information related to the protection of human subjects.
Without the information provided by industry as required under the IND
regulations, FDA cannot authorize or monitor the clinical
investigations that must be conducted before authorizing the sale and
general use of new drugs. These reports enable FDA to monitor a study's
progress, to ensure the safety of subjects, to ensure that a study will
be conducted ethically, and to increase the likelihood that the sponsor
will conduct studies that will be useful in determining whether the
drug should be marketed and available for use in medical practice.
To assist respondents with certain reporting requirements under
part 312, we have developed two forms: Form FDA 1571 entitled,
``Investigational New Drug Application (IND)'' and Form FDA 1572
entitled, ``Statement of Investigator.'' Anyone who intends to conduct
a clinical investigation must submit Form FDA 1571 as instructed. The
reporting elements include: (1) A cover sheet containing background
information on the sponsor and investigator; (2) a table of contents;
(3) an introductory statement and general investigational plan; (4) an
investigator's brochure describing the drug substance; (5) a protocol
for each planned study; (6) chemistry, manufacturing, and control
information for each investigation; (7) pharmacology and toxicology
information for each investigation; and (8) previous human experience
with the investigational drug. Form FDA 1572 is executed and submitted
by the IND sponsor before an investigator may participate in an
[[Page 50104]]
investigation. It includes background information on the investigator
as well as the investigation, and a general outline of the planned
investigation and study protocol.
Below, we estimate the burden of the information collection as
reported by FDA's Center for Drug Evaluation and Research (CDER) and
Center for Biologics Evaluation and Research (CBER) as follows:
Table 1--Estimated Annual Reporting Burden for Human Drugs (CDER) \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Sec. 312.2(e); Requests for 400 1 400 24 9,600
FDA advice on the applicability
of part 312 to a planned
clinical investigation.........
Sec. 312.8; Requests to charge 74 1.23 91 48 4,368
for an investigational drug....
Sec. 312.10; Requests to waive 86 1.84 158 24 3,792
a requirement in part 312......
Sec. 312.23(a) through (f); 2,187 1.7 3,718 1,600 5,948,800
IND content and format
(including Form FDA 1571)......
Sec. 312.30(a) through (e); 4,418 5.52 24,387 284 6,925,908
Protocol amendments............
Sec. 312.31(b); Information 6,691 3.32 22,214 100 2,221,400
amendments.....................
Sec. 312.32(c) and (d); IND 867 15.78 13,681 32 437,792
safety reports.................
Sec. 312.33(a) through (f); 3,376 2.86 9,655 360 3,475,800
IND annual reports.............
Sec. 312.38(b) and (c); 930 1.61 1,497 28 41,916
Notifications of withdrawal of
an IND.........................
Sec. 312.42; Sponsor requests 198 1.38 273 284 77,532
that a clinical hold be
removed, including sponsor
submission of a complete
response to the issues
identified in the clinical hold
order..........................
Sec. 312.44(c) and (d); 12 1.16 14 16 224
Sponsor responses to FDA when
IND is terminated..............
Sec. 312.45(a) and (b); 231 1.84 425 12 5,100
Sponsor requests for or
responses to an inactive status
determination of an IND by FDA.
Sec. 312.47; Meetings, 122 1.51 184 160 29,440
including ``End-of-Phase 2''
meetings and ``Pre-NDA''
meetings.......................
Sec. 312.54(a); Sponsor 15 2.4 36 48 1,728
submissions to FDA concerning
investigations involving an
exception from informed consent
under Sec. 50.24.............
Sec. 312.54(b); Sponsor 2 1 2 48 96
notifications to FDA and others
concerning an IRB determination
that it cannot approve research
because it does not meet the
criteria in the exception from
informed consent in Sec.
50.24(a).......................
Sec. 312.56(b), (c), and (d); 6,100 7 42,700 80 3,416,000
Sponsor notifications to FDA
and others resulting from: (1)
The sponsor's monitoring of all
clinical investigations and
determining that an
investigator is not in
compliance with the
investigation agreements; (2)
the sponsor's review and
evaluation of the evidence
relating to the safety and
effectiveness of the
investigational drug; and (3)
the sponsor's determination
that the investigational drug
presents an unreasonable and
significant risk to subjects...
Sec. 312.58(a); Sponsor's 73 1 73 8 584
submissions of clinical
investigation records to FDA on
request during FDA inspections.
Sec. 312.70; During the 4 1 4 40 160
disqualification process of a
clinical investigator by FDA,
the number of investigator
responses or requests to FDA
following FDA's notification to
an investigator of its failure
to comply with investigation
requirements...................
Sec. 312.110(b)(4) and (b)(5); 11 26.28 289 75 21,675
Written certifications and
written statements submitted to
FDA relating to the export of
an investigational drug........
Sec. 312.120(b); Submissions 1,414 8.62 12,189 32 390,048
to FDA of ``supporting
information'' related to the
use of foreign clinical studies
not conducted under an IND.....
Sec. 312.120(c); Waiver 35 2.34 82 24 1,968
requests submitted to FDA
related to the use of foreign
clinical studies not conducted
under an IND...................
Sec. 312.130; Requests for 3 1 3 8 24
disclosable information in an
IND and for investigations
involving an exception from
informed consent under Sec.
50.24..........................
Sec. Sec. 312.310(b) and 935 2.77 2,590 8 20,720
312.305(b); Submissions related
to expanded access and
treatment of an individual
patient........................
Sec. 312.310(d); Submissions 480 2.15 1,032 16 16,512
related to emergency use of an
investigational new drug.......
Sec. Sec. 312.315(c) and 118 2.52 297 120 35,640
312.305(b); Submissions related
to expanded access and
treatment of an intermediate-
size patient population........
Sec. 312.320(b); Submissions 10 12.9 129 300 38,700
related to a treatment IND or
treatment protocol.............
-------------------------------------------------------------------------------
[[Page 50105]]
Total....................... .............. .............. .............. .............. 23,125,527
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden for Human Drugs (CDER) \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Sec. 312.52(a); Sponsor 1,300 1 1,300 2 2,600
records for the transfer of
obligations to a contract
research organization..........
Sec. 312.57; Sponsor 13,000 1 13,000 100 1,300,000
recordkeeping showing the
receipt, shipment, or other
disposition of the
investigational drug and any
financial interests............
Sec. 312.62(a); Investigator 13,000 1 13,000 40 520,000
recordkeeping of the
disposition of drugs...........
Sec. 312.62(b); Investigator 13,000 1 13,000 40 520,000
recordkeeping of case histories
of individuals.................
Sec. 312.160(a)(3); Records 547 1.43 782 * 0.50 391
pertaining to the shipment of
drugs for investigational use
in laboratory research animals
or in vitro tests..............
Sec. 312.160(c); Shipper 547 1.43 782 * 0.50 391
records of alternative
disposition of unused drugs....
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 2,343,382
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
* 30 minutes.
Table 3--Estimated Annual Third-Party Disclosure Burden for Human Drugs (CDER) \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
Sec. 312.53(c); Investigator 1,732 7.94 13,752 80 1,100,160
reports submitted to the
sponsor, including Form FDA
1572, curriculum vitae,
clinical protocol, and
financial disclosure...........
Sec. 312.55(a); Investigator 995 4 3,980 48 191,040
brochures submitted by the
sponsor to each investigator...
Sec. 312.55(b); Sponsor 995 4 3,980 48 191,040
reports to investigators on new
observations, especially
adverse reactions and safe use.
Sec. 312.64; Investigator 13,000 1 13,000 24 312,000
reports to the sponsor,
including progress reports,
safety reports, final reports,
and financial disclosure
reports........................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,794,240
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 4--Estimated Annual Reporting Burden for Biologics (CBER) \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
312.2(e) Requests for FDA advice 217 1.18 256 24 6,144
on the applicability of part
312 to a planned clinical
investigation..................
312.8 Requests to charge for an 20 1.50 30 48 1,440
investigational drug...........
312.10 Requests to waive a 2 1 2 24 48
requirement in part 312........
312.23(a) through (f) IND 335 1.35 452 1,600 723,200
content and format.............
312.30(a) through (e) Protocol 694 5.84 4,053 284 1,151,052
amendments.....................
312.31(b) Information amendments 77 2.43 187 100 18,700
312.32(c) and (d) IND Safety 161 8.83 1,422 32 45,504
reports........................
312.33(a) through (f) IND Annual 745 2.14 1,594 360 573,840
reports........................
312.38(b) and (c) Notifications 134 1.69 226 28 6,328
of withdrawal of an IND........
[[Page 50106]]
312.42 Sponsor requests that a 67 1.30 87 284 24,708
clinical hold be removed,
including sponsor submission of
a complete response to the
issues identified in the
clinical hold order............
312.44(c) and (d) Sponsor 34 1.15 39 16 624
responses to FDA when IND is
terminated.....................
312.45(a) and (b) Sponsor 55 1.38 76 12 912
requests for or responses to an
inactive status determination
of an IND by FDA...............
312.47 Meetings, including ``End- 88 1.75 154 160 24,640
of-Phase 2'' meetings and ``Pre-
NDA'' meetings.................
312.53(c) Investigator reports 453 6.33 2,867 80 229,360
submitted to the sponsor,
including Form FDA-1572,
curriculum vitae, clinical
protocol, and financial
disclosure.....................
312.54(a) Sponsor submissions to 1 1 1 48 48
FDA concerning investigations
involving an exception from
informed consent under 21 CFR
50.24..........................
312.54(b) Sponsor notifications 1 1 1 48 48
to FDA and others concerning an
IRB determination that it
cannot approve research because
it does not meet the criteria
in the exception from informed
consent in 50.24(a)............
312.55(a) Number of investigator 239 1.91 456 48 21,888
brochures submitted by the
sponsor to each investigator...
312.55(b) Number of sponsor 243 4.95 1,203 48 57,744
reports to investigators on new
observations, especially
adverse reactions and safe use.
312.56(b), (c), and (d) Sponsor 108 2.21 239 80 19,120
notifications to FDA and others
resulting from: (1) The
sponsor's monitoring of all
clinical investigations and
determining that an
investigator is not in
compliance with the
investigation agreements; (2)
the sponsor's review and
evaluation of the evidence
relating to the safety and
effectiveness of the
investigational drug; and (3)
the sponsor's determination
that the investigational drug
presents an unreasonable and
significant risk to subjects...
312.58(a) Number of sponsor's 7 1 7 8 56
submissions of clinical
investigation records to FDA on
request during FDA inspections.
312.64 Number of investigator 2,728 3.82 10,421 24 250,104
reports to the sponsor,
including progress reports,
safety reports, final reports,
and financial disclosure
reports........................
312.70 During the 5 1 5 40 200
disqualification process of a
clinical investigator by FDA,
the number of investigator
responses or requests to FDA
following FDA's notification to
an investigator of its failure
to comply with investigation
requirements...................
312.110(b)(4) and (b)(5) Number 18 1 18 75 1,350
of written certifications and
written statements submitted to
FDA relating to the export of
an investigational drug........
312.120(b) Number of submissions 280 9.82 2,750 32 88,000
to FDA of ``supporting
information'' related to the
use of foreign clinical studies
not conducted under an IND.....
312.120(c) Number of waiver 7 2.29 16 24 384
requests submitted to FDA
related to the use of foreign
clinical studies not conducted
under an IND...................
312.130 Number of requests for 350 1.34 469 8 3,752
disclosable information in an
IND and for investigations
involving an exception from
informed consent under Sec.
50.24..........................
312.310(b) and 312.305(b) Number 78 1.08 84 8 672
of submissions related to
expanded access and treatment
of an individual patient.......
312.310(d) Number of submissions 76 2.76 210 16 3,360
related to emergency use of an
investigational new drug.......
312.315(c) and 312.305(b) Number 9 1 9 120 1,080
of submissions related to
expanded access and treatment
of an intermediate-size patient
population.....................
312.320(b) Number of submissions 1 1 1 300 300
related to a treatment IND or
treatment protocol.............
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 3,254,606
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 50107]]
Table 5--Estimated Annual Recordkeeping Burden for Biologics (CBER) \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
312.52(a) Sponsor records for 75 1.40 105 2 210
the transfer of obligations to
a contract research
organization...................
312.57 Sponsor recordkeeping 335 2.70 904 100 90,400
showing the receipt, shipment,
or other disposition of the
investigational drug, and any
financial interests............
312.62(a) Investigator 453 1 453 40 18,120
recordkeeping of the
disposition of drugs...........
312.62(b) Investigator 453 1 453 40 18,120
recordkeeping of case histories
of individuals.................
312.160(a)(3) Records pertaining 111 1.40 155 * 0.5 78
to the shipment of drugs for
investigational use in
laboratory research animals or
in vitro tests.................
312.160(c) Shipper records of 111 1.40 155 * 0.5 78
alternative disposition of
unused drugs...................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 127,006
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
* 30 minutes.
Because we have received an increased number of IND submissions
since the last OMB approval of the information collection, we have
increased our estimate of the associated burden accordingly.
Dated: September 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21610 Filed 10-3-18; 8:45 am]
BILLING CODE 4164-01-P
