Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational New Drug Regulations, 21690-21696 [E9-10730]
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21690
Federal Register / Vol. 74, No. 88 / Friday, May 8, 2009 / Notices
Statewide Assessment; CFSR On-site
Review; CFSR Program Improvement
Plan; and Anti-Discrimination
Enforcement Corrective Action Plan.
The collection of information for review
of Federal payments to States for foster
care maintenance payments (45 CFR
1356.71(i)) is authorized by title IV–E of
the Social Security Act (the Act), section
474 [42 U.S.C. 674]. The Foster Care
Eligibility Reviews (FCER) ensure that
States claim title IV–E funds only on
behalf of title IV–E eligible children.
The collection of information for review
of State child and family services
programs (45 CFR 1355.33(b), 1355.33(c)
and 1355.35(a)) is to determine whether
such programs are in substantial
conformity with State plan requirements
under parts B and E of the Act and is
authorized by section 1123(a) [42 U.S.C
1320a–1a] of the Act. The CFSR looks at
the outcomes related to safety,
permanency and well-being of children
served by the child welfare system and
at seven systemic factors that support
the outcomes. Section 474(d) of the Act
[42 U.S.C 674] deploys enforcement
provisions (45 CFR 1355.38(b) and (c))
for the requirements at section
4371(a)(18) [42 U.S.C 671], which
prohibit the delay or denial of foster and
adoptive placements based on the race,
color, or national origin of any of the
individuals involved. The enforcement
provisions include the execution and
completion of corrective action plans
when a State is in violation of section
471(a)(18) of the Act. The information
collection is needed: (1) To ensure
compliance with title IV–E foster care
eligibility requirements; (2) to monitor
State plan requirements under titles IV–
B and IV–E of the Act, as required by
Federal statute; and (3) to enforce the
title IV–E anti-discrimination
requirements through State corrective
action plans. The resultant information
will allow ACF to determine if States
are in compliance with State plan
requirements and are achieving desired
outcomes for children and families, help
ensure that claims by States for title IV–
E funds are made only on behalf of title
IV–E eligible children, and require
States to revise applicable statutes,
rules, policies and procedures, and
provide proper training to staff, through
the development and implementation of
corrective action plans. These reviews
not only address compliance with
eligibility requirements but also assist
States in enhancing the capacities to
serve children and families. In
computing the number of burden hours
for this information collection, ACF
based the annual burden estimates on
ACF’s and States’ experiences in
conducting reviews and developing
program improvement plans.
Respondents: State Title IV–B and
Title IV–E Agencies.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
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45
45
45
45
45
CFR
CFR
CFR
CFR
CFR
1356.7 (i) Program Improvement Plan (FCER) .................................
1366.33 (b) Statewide Assessment (CFSR) ......................................
1355.33 (c) On-site Review (CFSR) ..................................................
1355.35 (a) Program Improvement Plan (CFSR) ..............................
1355.38 (b) and (c) Corrective Action ...............................................
Estimated Total Annual Burden
Hours: 22,860
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
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13
13
13
1
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: May 5, 2009.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E9–10703 Filed 5–7–09; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0030]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Investigational
New Drug Regulations
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
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Number of
responses per
respondent
Average
burden hours
per response
1
1
1
1
1
ACTION:
90
240
1,170
240
780
Total burden
hours
630
3,120
15,210
3,120
780
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by June 8,
2009.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
oiralsubmission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0014. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–796–3792.
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Federal Register / Vol. 74, No. 88 / Friday, May 8, 2009 / Notices
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Investigational New Drug Regulations—
OMB Control Number 0910–0014—
Extension
FDA is requesting OMB approval for
the reporting and recordkeeping
requirements contained in the FDA
regulations ‘‘Investigational New Drug
Application’’ in part 312 (21 CFR part
312). Part 312 implements provisions of
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i)) (the
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 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 do 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 in
response to the IND regulations, FDA
cannot authorize or monitor the clinical
investigations which must be conducted
21691
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.
The second form is 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:
TABLE 1.—REPORTING AND RECORDKEEPING REQUIREMENTS IN 21 CFR PART 312
REPORTING REQUIREMENTS
21 CFR Section
.
312.7(d) ..................................
.
312.8 ......................................
312.10 ....................................
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.
312.20(c) ................................
.
312.23 ....................................
(a)(1) ...................................
(a)(2) ...................................
(a)(3) ...................................
(a)(5) ...................................
(a)(6) ...................................
(a)(7) ...................................
(a)(7)(iv)(a), (b), and (c)
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Requirements
Applications for permission to sell an investigational new drug
Charging for investigational drugs under an IND
Applications for waiver of requirements under part 312; as indicated in § 312.10(a), estimates for this requirement are included under §§ 312.23 and 312.31. In addition, separate requests under § 312.10 are estimated in
table 2 of this document.
Applications for investigations involving an exception from informed consent under § 50.24 (21 CFR 50.24); estimates for this requirement are included under § 312.23.
INDs (content and format)
Cover sheet FDA–1571
Table of contents
Investigational plan for each planned study
Investigator’s brochure
Protocols—Phases 1, 2, and 3
Chemistry, manufacturing, and control information
A description of the drug substance, a list of all components, and any placebo used
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TABLE 1.—REPORTING AND RECORDKEEPING REQUIREMENTS IN 21 CFR PART 312—Continued
REPORTING REQUIREMENTS
21 CFR Section
(a)(7)(iv)(d) .........................
(a)(7)(iv)(e) .........................
(a)(8) ...................................
(a)(9) ...................................
(a)(10) .................................
(a)(11) .................................
(f) ........................................
.
312.30 ....................................
(a) .......................................
(b) .......................................
(c) .......................................
(d) .......................................
(e) .......................................
.
312.31 ....................................
(b) .......................................
.
312.32 ....................................
(c)(1) ...................................
(c)(2) ...................................
(c)(3) ...................................
(d) .......................................
.
312.33 ....................................
(a) .......................................
(b) .......................................
(b)(1) ...................................
(b)(2) ...................................
(b)(3) ...................................
(b)(4) ...................................
(b)(5) ...................................
(b)(6) ...................................
(b)(7) ...................................
(c) .......................................
(d) .......................................
(e) .......................................
(f) ........................................
.
312.35 ....................................
(a) .......................................
(b) .......................................
.
312.36 ....................................
.
312.38(b) and (c) ...................
.
312.42(e) ................................
.
312.44(c) and (d) ...................
.
312.45(a) and (b) ...................
.
312.47(b) ................................
.
312.53(c) ................................
hsrobinson on PROD1PC76 with NOTICES
.
312.54(a) and (b) ...................
.
312.55(b) ................................
.
312.56(b), (c), and (d) ...........
.
312.58(a) ................................
.
312.64 ....................................
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Requirements
Labeling: Copies of labels and labeling to be provided each investigator
Environmental impact analysis regarding drug manufacturing and use
Pharmacological and toxicology information
Previous human experience with the investigational drug
Additional information
Relevant information
Identification of exception from informed consent
Protocol amendments
New protocol
Change in protocol
New investigator
Content and format
Frequency
Information amendments
Content and format
Chemistry, toxicology, or technical information
Safety reports
Written reports to FDA and to investigators
Telephone reports to FDA for fatal or life-threatening experience
Format or frequency
Followup submissions
Annual reports
Individual study information
Summary information
Adverse experiences
Safety report summary
List of fatalities and causes of death
List of discontinuing subjects
Drug action
Preclinical studies and findings
Significant changes
Next year general investigational plan
Brochure revision
Phase I protocol modifications
Foreign marketing developments
Treatment use of investigational new drugs
Treatment protocol submitted by IND sponsor
Treatment IND submitted by licensed practitioner
Requests for emergency use of an investigational new drug
Notification of withdrawal of an IND
Sponsor requests that a clinical hold be removed and submits a complete response to the issues identified in
the clinical hold order
Opportunity for sponsor response to FDA when IND is terminated
Sponsor request for, or response to, inactive status determination of an IND
‘‘End-of-Phase 2’’ meetings and ‘‘Pre-NDA’’ meetings
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
Sponsor submissions concerning investigations involving an exception from informed consent under § 50.24
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
Sponsor monitoring of all clinical investigations, investigators, and drug safety; notification to FDA
Sponsor’s submission of records to FDA on request
Investigator reports to the sponsor
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Federal Register / Vol. 74, No. 88 / Friday, May 8, 2009 / Notices
TABLE 1.—REPORTING AND RECORDKEEPING REQUIREMENTS IN 21 CFR PART 312—Continued
REPORTING REQUIREMENTS
21 CFR Section
(a) .......................................
(b) .......................................
(c) .......................................
.
312.66 ....................................
.
312.70(a) ................................
.
312.83 ....................................
.
312.85 ....................................
.
312.110(b) ..............................
.
312.120 ..................................
.
312.130(d) ..............................
Requirements
Progress reports
Safety reports
Final reports
Investigator reports to Institutional Review Board; estimates for this requirement are included under § 312.53
Investigator disqualification; opportunity to respond to FDA
Sponsor submission of treatment protocol; estimates for this requirement are included under §§ 312.34 and
312.35
Sponsors conducting Phase 4 studies; estimates for this requirement are included under § 312.23 in 0910–0014,
and §§ 314.50, 314.70, and 314.81 in 0910–0001
Request to export an investigational drug
Submissions related to foreign clinical studies not conducted under an IND
Request for disclosable information for investigations involving an exception from informed consent under
§ 50.24
RECORDKEEPING REQUIREMENTS
21 CFR Section
312.52(a) ................................
.
312.57 ....................................
.
312.59 ....................................
.
312.62(a) ................................
.
312.62(b) ................................
.
312.120(d) ..............................
.
312.160(a)(3) .........................
.
312.160(c) ..............................
Requirements
Transfer of obligations to a contract research organization
Sponsor recordkeeping
Sponsor recordkeeping of disposition of unused supply of drugs; estimates for this requirement are included
under § 312.57
Investigator recordkeeping of disposition of drugs
Investigator recordkeeping of case histories of individuals
Recordkeeping requirements for submissions related to foreign clinical studies not conducted under an IND; estimates for this requirement are included under § 312.57
Records maintenance: shipment of drugs for investigational use in laboratory research animals or in vitro tests
Shipper records of alternative disposition of unused drugs
In the Federal Register of February
11, 2009 (74 FR 6889), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
In tables 2 and 3 of this document, the
estimates for ‘‘No. of Respondents,’’
‘‘No. of Responses per Respondent,’’
and ‘‘Total Annual Responses’’ were
obtained from the Center for Drug
Evaluation and Research (CDER) and the
Center for Biologics Evaluation and
Research (CBER) reports and data
management systems for submissions
received in 2007 and from other sources
familiar with the number of submissions
received under 21 CFR part 312. The
estimates for ‘‘Hours per Response’’
were made by CDER and CBER
individuals familiar with the burden
associated with these reports and from
estimates received from the
pharmaceutical industry.
FDA estimates the burden of this
collection of information as follows:
TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS AND BIOLOGICS (CDER)1
No. of
Respondents
21 CFR Section
No. of Responses
per Respondent
Total Annual
Responses
Hours per
Response
Total Hours
hsrobinson on PROD1PC76 with NOTICES
312.7(d)
28
1.58
44
24
1,056
312.10
4
1
4
10
40
312.23(a) through (f)
2,496
1.26
3,156
1,600
5,049,600
312.30(a) through (e)
2,030
8.91
18,079
284
5,134,436
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Federal Register / Vol. 74, No. 88 / Friday, May 8, 2009 / Notices
TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS AND BIOLOGICS (CDER)1—Continued
No. of
Respondents
21 CFR Section
No. of Responses
per Respondent
Total Annual
Responses
Hours per
Response
Total Hours
312.31(b)
153
2.97
454
100
45,400
312.32(c) and (d)
985
23.06
22,713
32
726,816
2,564
2.34
5,994
360
2,157,840
9
1.11
10
300
3,000
312.36
525
1.23
645
16
10,320
312.38(b) and (c)
654
1.34
874
28
24,472
312.42(e)
149
1.10
164
284
46,576
312.44(c) and (d)
159
1.13
179
16
2,864
312.45(a) and (b)
254
1.43
362
12
4,344
312.47(b)
281
1.8
529
160
84,640
312.53(c)
900
26.51
23,855
80
1,908,400
1
1
1
48
48
985
2,306
2,271,300
48
109,022,400
312.56(b) ,(c), and (d)
18
1
18
80
1,440
312.58(a)
91
4.10
373
8
2,984
141,393
1
141,393
24
3,393,432
312.70(a)
4
1.5
6
40
240
312.110(b)
23
18.26
420
75
31,500
115
5
575
32
18,400
3
1
3
8
24
312.33(a) through (f)
312.35(a) and (b)
312.54(a) and (b)
312.55(b)
312.64
312.1202
312.130(d)
1 There
are no capital and startup, or operation, maintenance, and purchase costs associated with the collection of information requirements.
312.120 includes the burden estimate for both CDER and CBER.
2 Section
TABLE 3.—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR HUMAN DRUGS AND BIOLOGICS (CDER)1
No. of
Recordkeepers
21 CFR Section
312.52(a)
No. of Records
per Recordkeeper
Total Annual
Records
Hours per
Record
Total Hours
683
1
683
2
1,366
75
485.28
36,396
100
3,639,600
312.62(a)
14,732
1
14,732
40
589,280
312.62(b)
147,320
1
147,320
40
5,892,800
312.160(a)(3)
547
1.4
782
.5
391
312.160(c)
547
1.4
782
.5
391
312.57
1 There
are no capital and startup, or operation, maintenance, and purchase costs associated with the collection of information requirements.
TABLE 4.—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS (CBER)1
No. of
Respondents
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21 CFR Section
312.7(d)
No. of Responses
per Respondent
Total Annual
Responses
Hours per
Responses
Total Hours
12
1.1
13
24
312
(f)2
168
1.5
256
1,600
409,600
312.30(a) through (e)
372
6.4
2,369
284
672,796
312.23(a) through
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TABLE 4.—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS (CBER)1—Continued
No. of
Respondents
21 CFR Section
No. of Responses
per Respondent
Total Annual
Responses
Hours per
Responses
Total Hours
312.31(b)2
703
7.7
5,417
100
541,700
312.32(c) and (d)
175
14.6
2,563
32
82,016
312.33(a) through (f)
512
2.3
1,168
360
420,480
1
1
1
300
300
312.36
10
4
40
16
640
312.38(b) and (c)
81
1.5
120
28
3,360
312.42(e)
74
1.5
108
284
30,672
312.44(c) and (d)
34
1.1
39
16
624
312.45(a) and (b)
41
1.4
59
12
708
312.47(b)
31
1.2
37
160
5,920
312.53(c)
243
4.95
1,203
80
96,240
1
1
1
48
48
312.55(b)
42
1
43
48
2,064
312.56(b), (c), and (d)
10
1.6
16
80
1,280
7
1
7
8
56
2,728
3.82
10,411
24
249,864
312.70(a)
5
1
5
40
200
312.110(b)
18
1
18
75
1,350
312.130(d)
1
1
1
8
8
312.35(a) and (b)
312.54(a) and (b)
312.58(a)
312.64
1 There
2 The
are no capital and startup, or operation, maintenance, and purchase costs associated with the collection of information requirements.
reporting requirement for § 312.10 is included in the estimates for §§ 312.23 and 312.31.
TABLE 5.—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS (CBER)1
No. of
Recordkeepers
21 CFR Section
312.52(a)
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
52
1.4
73
2
146
168
3.05
512
100
51,200
312.62(a)
2,560
1
2,560
40
102,400
312.62(b)
2,560
10
25,600
40
1,024,000
312.160(a)(3)
55
1.4
77
0.5
38.5
312.160(c)
55
1.4
77
0.5
38.5
312.57
hsrobinson on PROD1PC76 with NOTICES
1 There
are no capital and startup, or operation, maintenance, and purchase costs associated with the collection of information requirements.
VerDate Nov<24>2008
17:51 May 07, 2009
Jkt 217001
PO 00000
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Fmt 4703
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E:\FR\FM\08MYN1.SGM
08MYN1
21696
Federal Register / Vol. 74, No. 88 / Friday, May 8, 2009 / Notices
TABLE 6.—TOTALS FOR ESTIMATED
ANNUAL REPORTING AND RECORDKEEPING BURDENS FOR CDER
AND CBER
Reporting Burden
Recordkeeping
Total
130,190,510
11,301,652
141,492,162
Dated: May 1, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–10730 Filed 5–7–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–E–0048] (formerly
Docket No. 2007E–0445)
Determination of Regulatory Review
Period for Purposes of Patent
Extension; NEUPRO TRANSDERMAL
SYSTEM
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
hsrobinson on PROD1PC76 with NOTICES
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
NEUPRO TRANSDERMAL SYSTEM
and is publishing this notice of that
determination as required by law. FDA
has made the determination because of
the submission of an application to the
Director of Patents and Trademarks,
Department of Commerce, for the
extension of a patent which claims that
human drug product.
ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
VerDate Nov<24>2008
17:51 May 07, 2009
Jkt 217001
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the human drug
product becomes effective and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the human drug product and continues
until FDA grants permission to market
the drug product. Although only a
portion of a regulatory review period
may count toward the actual amount of
extension that the Director of Patents
and Trademarks may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA recently approved for marketing
the human drug product NEUPRO
TRANSDERMAL SYSTEM (rotigotine).
NEUPRO TRANSDERMAL SYSTEM is
indicated for the treatment of the signs
and symptoms of early-stage idiopathic
Parkinson’s disease. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for NEUPRO
TRANSDERMAL SYSTEM (U.S. Patent
No. 6,884,434) from Schwarz Pharma
Limited, and the Patent and Trademark
Office requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
April 28, 2008, FDA advised the Patent
and Trademark Office that this human
drug product had undergone a
regulatory review period and that the
approval of NEUPRO TRANSDERMAL
SYSTEM represented the first permitted
commercial marketing or use of the
product. Shortly thereafter, the Patent
and Trademark Office requested that
FDA determine the product’s regulatory
review period.
FDA has determined that the
applicable regulatory review period for
NEUPRO TRANSDERMAL SYSTEM is
4,367 days. Of this time, 3,535 days
occurred during the testing phase of the
regulatory review period, while 832
days occurred during the approval
PO 00000
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Fmt 4703
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phase. These periods of time were
derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
355(i)) became effective: May 27, 1995.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on May 27, 1995.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: January 28, 2005. The
applicant claims January 19, 2005, as
the date the new drug application
(NDA) for NEUPRO TRANSDERMAL
SYSTEM (NDA 21–829) was initially
submitted. However, FDA records
indicate that NDA 21–829 was initially
submitted on January 28, 2005, the date
of receipt by the Agency of a
resubmission following a refusal to file.
3. The date the application was
approved: May 9, 2007. FDA has
verified the applicant’s claim that NDA
21–829 was approved on May 9, 2007.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 744 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments and ask for a
redetermination by July 7, 2009.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
November 4, 2009. To meet its burden,
the petition must contain sufficient facts
to merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Comments and petitions should be
submitted to the Division of Dockets
Management. Three copies of any
mailed information are to be submitted,
except that individuals may submit one
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. Comments and petitions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
E:\FR\FM\08MYN1.SGM
08MYN1
]]>Agencies
[Federal Register Volume 74, Number 88 (Friday, May 8, 2009)]
[Notices]
[Pages 21690-21696]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-10730]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0030]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Investigational New
Drug Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by June 8,
2009.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0014.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3792.
[[Page 21691]]
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Investigational New Drug Regulations--OMB Control Number 0910-0014--
Extension
FDA is requesting OMB approval for the reporting and recordkeeping
requirements contained in the FDA regulations ``Investigational New
Drug Application'' in part 312 (21 CFR part 312). Part 312 implements
provisions of section 505(i) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(i)) (the 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 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 do 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 in response to 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.
The second form is 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:
Table 1.--Reporting and Recordkeeping Requirements in 21 CFR Part 312
------------------------------------------------------------------------
REPORTING REQUIREMENTS
-------------------------------------------------------------------------
21 CFR Section Requirements
------------------------------------------------------------------------
312.7(d).......................... Applications for permission to sell
an investigational new drug
312.8............................. Charging for investigational drugs
under an IND
312.10............................ Applications for waiver of
requirements under part 312; as
indicated in Sec. 312.10(a),
estimates for this requirement are
included under Sec. Sec. 312.23
and 312.31. In addition, separate
requests under Sec. 312.10 are
estimated in table 2 of this
document.
312.20(c)......................... Applications for investigations
involving an exception from
informed consent under Sec. 50.24
(21 CFR 50.24); estimates for this
requirement are included under Sec.
312.23.
312.23............................ INDs (content and format)
(a)(1).......................... Cover sheet FDA-1571
(a)(2).......................... Table of contents
(a)(3).......................... Investigational plan for each
planned study
(a)(5).......................... Investigator's brochure
(a)(6).......................... Protocols--Phases 1, 2, and 3
(a)(7).......................... Chemistry, manufacturing, and
control information
(a)(7)(iv)(a), (b), and (c) A description of the drug
substance, a list of all components,
and any placebo used
[[Page 21692]]
(a)(7)(iv)(d)................... Labeling: Copies of labels and
labeling to be provided each
investigator
(a)(7)(iv)(e)................... Environmental impact analysis
regarding drug manufacturing and use
(a)(8).......................... Pharmacological and toxicology
information
(a)(9).......................... Previous human experience with the
investigational drug
(a)(10)......................... Additional information
(a)(11)......................... Relevant information
(f)............................. Identification of exception from
informed consent
312.30............................ Protocol amendments
(a)............................. New protocol
(b)............................. Change in protocol
(c)............................. New investigator
(d)............................. Content and format
(e)............................. Frequency
312.31............................ Information amendments
(b)............................. Content and format
Chemistry, toxicology, or technical
information
312.32............................ Safety reports
(c)(1).......................... Written reports to FDA and to
investigators
(c)(2).......................... Telephone reports to FDA for fatal
or life-threatening experience
(c)(3).......................... Format or frequency
(d)............................. Followup submissions
312.33............................ Annual reports
(a)............................. Individual study information
(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
(c)............................. Next year general investigational
plan
(d)............................. Brochure revision
(e)............................. Phase I protocol modifications
(f)............................. Foreign marketing developments
312.35............................ Treatment use of investigational new
drugs
(a)............................. Treatment protocol submitted by
IND sponsor
(b)............................. Treatment IND submitted by
licensed practitioner
312.36............................ Requests for emergency use of an
investigational new drug
312.38(b) and (c)................. Notification of withdrawal of an IND
312.42(e)......................... Sponsor requests that a clinical
hold be removed and submits a
complete response to the issues
identified in the clinical hold
order
312.44(c) and (d)................. Opportunity for sponsor response to
FDA when IND is terminated
312.45(a) and (b)................. Sponsor request for, or response to,
inactive status determination of an
IND
312.47(b)......................... ``End-of-Phase 2'' meetings and
``Pre-NDA'' meetings
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
312.54(a) and (b)................. Sponsor submissions concerning
investigations involving an
exception from informed consent
under Sec. 50.24
312.55(b)......................... Sponsor reports to investigators on
new observations, especially
adverse reactions and safe use;
only ``new observations'' are
estimated under this section;
investigator brochures are included
under Sec. 312.23
312.56(b), (c), and (d)........... Sponsor monitoring of all clinical
investigations, investigators, and
drug safety; notification to FDA
312.58(a)......................... Sponsor's submission of records to
FDA on request
312.64............................ Investigator reports to the sponsor
[[Page 21693]]
(a)............................. Progress reports
(b)............................. Safety reports
(c)............................. Final reports
312.66............................ Investigator reports to
Institutional Review Board;
estimates for this requirement are
included under Sec. 312.53
312.70(a)......................... Investigator disqualification;
opportunity to respond to FDA
312.83............................ Sponsor submission of treatment
protocol; estimates for this
requirement are included under Sec.
Sec. 312.34 and 312.35
312.85............................ Sponsors conducting Phase 4 studies;
estimates for this requirement are
included under Sec. 312.23 in
0910-0014, and Sec. Sec. 314.50,
314.70, and 314.81 in 0910-0001
312.110(b)........................ Request to export an investigational
drug
312.120........................... Submissions related to foreign
clinical studies not conducted
under an IND
312.130(d)........................ Request for disclosable information
for investigations involving an
exception from informed consent
under Sec. 50.24
------------------------------------------------------------------------
------------------------------------------------------------------------
RECORDKEEPING REQUIREMENTS
-------------------------------------------------------------------------
21 CFR Section Requirements
------------------------------------------------------------------------
312.52(a)......................... Transfer of obligations to a
contract research organization
312.57............................ Sponsor recordkeeping
312.59............................ Sponsor recordkeeping of disposition
of unused supply of drugs;
estimates for this requirement are
included under Sec. 312.57
312.62(a)......................... Investigator recordkeeping of
disposition of drugs
312.62(b)......................... Investigator recordkeeping of case
histories of individuals
312.120(d)........................ Recordkeeping requirements for
submissions related to foreign
clinical studies not conducted
under an IND; estimates for this
requirement are included under Sec.
312.57
312.160(a)(3)..................... Records maintenance: 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
------------------------------------------------------------------------
In the Federal Register of February 11, 2009 (74 FR 6889), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
In tables 2 and 3 of this document, the estimates for ``No. of
Respondents,'' ``No. of Responses per Respondent,'' and ``Total Annual
Responses'' were obtained from the Center for Drug Evaluation and
Research (CDER) and the Center for Biologics Evaluation and Research
(CBER) reports and data management systems for submissions received in
2007 and from other sources familiar with the number of submissions
received under 21 CFR part 312. The estimates for ``Hours per
Response'' were made by CDER and CBER individuals familiar with the
burden associated with these reports and from estimates received from
the pharmaceutical industry.
FDA estimates the burden of this collection of information as
follows:
Table 2.--Estimated Annual Reporting Burden for Human Drugs and Biologics (CDER)\1\
----------------------------------------------------------------------------------------------------------------
No. of No. of Responses Total Annual Hours per
21 CFR Section Respondents per Respondent Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
312.7(d) 28 1.58 44 24 1,056
----------------------------------------------------------------------------------------------------------------
312.10 4 1 4 10 40
----------------------------------------------------------------------------------------------------------------
312.23(a) through 2,496 1.26 3,156 1,600 5,049,600
(f)
----------------------------------------------------------------------------------------------------------------
312.30(a) through 2,030 8.91 18,079 284 5,134,436
(e)
----------------------------------------------------------------------------------------------------------------
[[Page 21694]]
312.31(b) 153 2.97 454 100 45,400
----------------------------------------------------------------------------------------------------------------
312.32(c) and (d) 985 23.06 22,713 32 726,816
----------------------------------------------------------------------------------------------------------------
312.33(a) through 2,564 2.34 5,994 360 2,157,840
(f)
----------------------------------------------------------------------------------------------------------------
312.35(a) and (b) 9 1.11 10 300 3,000
----------------------------------------------------------------------------------------------------------------
312.36 525 1.23 645 16 10,320
----------------------------------------------------------------------------------------------------------------
312.38(b) and (c) 654 1.34 874 28 24,472
----------------------------------------------------------------------------------------------------------------
312.42(e) 149 1.10 164 284 46,576
----------------------------------------------------------------------------------------------------------------
312.44(c) and (d) 159 1.13 179 16 2,864
----------------------------------------------------------------------------------------------------------------
312.45(a) and (b) 254 1.43 362 12 4,344
----------------------------------------------------------------------------------------------------------------
312.47(b) 281 1.8 529 160 84,640
----------------------------------------------------------------------------------------------------------------
312.53(c) 900 26.51 23,855 80 1,908,400
----------------------------------------------------------------------------------------------------------------
312.54(a) and (b) 1 1 1 48 48
----------------------------------------------------------------------------------------------------------------
312.55(b) 985 2,306 2,271,300 48 109,022,400
----------------------------------------------------------------------------------------------------------------
312.56(b) ,(c), 18 1 18 80 1,440
and (d)
----------------------------------------------------------------------------------------------------------------
312.58(a) 91 4.10 373 8 2,984
----------------------------------------------------------------------------------------------------------------
312.64 141,393 1 141,393 24 3,393,432
----------------------------------------------------------------------------------------------------------------
312.70(a) 4 1.5 6 40 240
----------------------------------------------------------------------------------------------------------------
312.110(b) 23 18.26 420 75 31,500
----------------------------------------------------------------------------------------------------------------
312.120\2\ 115 5 575 32 18,400
----------------------------------------------------------------------------------------------------------------
312.130(d) 3 1 3 8 24
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital and startup, or operation, maintenance, and purchase costs associated with the
collection of information requirements.
\2\ Section 312.120 includes the burden estimate for both CDER and CBER.
Table 3.--Estimated Annual Recordkeeping Burden for Human Drugs and Biologics (CDER)\1\
----------------------------------------------------------------------------------------------------------------
No. of No. of Records Total Annual Hours per
21 CFR Section Recordkeepers per Recordkeeper Records Record Total Hours
----------------------------------------------------------------------------------------------------------------
312.52(a) 683 1 683 2 1,366
----------------------------------------------------------------------------------------------------------------
312.57 75 485.28 36,396 100 3,639,600
----------------------------------------------------------------------------------------------------------------
312.62(a) 14,732 1 14,732 40 589,280
----------------------------------------------------------------------------------------------------------------
312.62(b) 147,320 1 147,320 40 5,892,800
----------------------------------------------------------------------------------------------------------------
312.160(a)(3) 547 1.4 782 .5 391
----------------------------------------------------------------------------------------------------------------
312.160(c) 547 1.4 782 .5 391
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital and startup, or operation, maintenance, and purchase costs associated with the
collection of information requirements.
Table 4.--Estimated Annual Reporting Burden for Biologics (CBER)\1\
----------------------------------------------------------------------------------------------------------------
No. of No. of Responses Total Annual Hours per
21 CFR Section Respondents per Respondent Responses Responses Total Hours
----------------------------------------------------------------------------------------------------------------
312.7(d) 12 1.1 13 24 312
----------------------------------------------------------------------------------------------------------------
312.23(a) through 168 1.5 256 1,600 409,600
(f)\2\
----------------------------------------------------------------------------------------------------------------
312.30(a) through 372 6.4 2,369 284 672,796
(e)
----------------------------------------------------------------------------------------------------------------
[[Page 21695]]
312.31(b)\2\ 703 7.7 5,417 100 541,700
----------------------------------------------------------------------------------------------------------------
312.32(c) and (d) 175 14.6 2,563 32 82,016
----------------------------------------------------------------------------------------------------------------
312.33(a) through 512 2.3 1,168 360 420,480
(f)
----------------------------------------------------------------------------------------------------------------
312.35(a) and (b) 1 1 1 300 300
----------------------------------------------------------------------------------------------------------------
312.36 10 4 40 16 640
----------------------------------------------------------------------------------------------------------------
312.38(b) and (c) 81 1.5 120 28 3,360
----------------------------------------------------------------------------------------------------------------
312.42(e) 74 1.5 108 284 30,672
----------------------------------------------------------------------------------------------------------------
312.44(c) and (d) 34 1.1 39 16 624
----------------------------------------------------------------------------------------------------------------
312.45(a) and (b) 41 1.4 59 12 708
----------------------------------------------------------------------------------------------------------------
312.47(b) 31 1.2 37 160 5,920
----------------------------------------------------------------------------------------------------------------
312.53(c) 243 4.95 1,203 80 96,240
----------------------------------------------------------------------------------------------------------------
312.54(a) and (b) 1 1 1 48 48
----------------------------------------------------------------------------------------------------------------
312.55(b) 42 1 43 48 2,064
----------------------------------------------------------------------------------------------------------------
312.56(b), (c), 10 1.6 16 80 1,280
and (d)
----------------------------------------------------------------------------------------------------------------
312.58(a) 7 1 7 8 56
----------------------------------------------------------------------------------------------------------------
312.64 2,728 3.82 10,411 24 249,864
----------------------------------------------------------------------------------------------------------------
312.70(a) 5 1 5 40 200
----------------------------------------------------------------------------------------------------------------
312.110(b) 18 1 18 75 1,350
----------------------------------------------------------------------------------------------------------------
312.130(d) 1 1 1 8 8
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital and startup, or operation, maintenance, and purchase costs associated with the
collection of information requirements.
\2\ The reporting requirement for Sec. 312.10 is included in the estimates for Sec. Sec. 312.23 and 312.31.
Table 5.--Estimated Annual Recordkeeping Burden for Biologics (CBER)\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers per Recordkeeping Records Record Total Hours
----------------------------------------------------------------------------------------------------------------
312.52(a) 52 1.4 73 2 146
----------------------------------------------------------------------------------------------------------------
312.57 168 3.05 512 100 51,200
----------------------------------------------------------------------------------------------------------------
312.62(a) 2,560 1 2,560 40 102,400
----------------------------------------------------------------------------------------------------------------
312.62(b) 2,560 10 25,600 40 1,024,000
----------------------------------------------------------------------------------------------------------------
312.160(a)(3) 55 1.4 77 0.5 38.5
----------------------------------------------------------------------------------------------------------------
312.160(c) 55 1.4 77 0.5 38.5
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital and startup, or operation, maintenance, and purchase costs associated with the
collection of information requirements.
[[Page 21696]]
Table 6.--Totals for Estimated Annual Reporting and Recordkeeping
Burdens for CDER and CBER
Reporting Burden 130,190,510
------------------------------------------------------------------------
Recordkeeping 11,301,652
------------------------------------------------------------------------
Total 141,492,162
------------------------------------------------------------------------
Dated: May 1, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-10730 Filed 5-7-09; 8:45 am]
BILLING CODE 4160-01-S
