Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational Use, 19073-19074 [E8-7255]
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Federal Register / Vol. 73, No. 68 / Tuesday, April 8, 2008 / Notices
ANNUAL BURDEN ESTIMATES
Number of
responses per
respondent
Number of
respondents
Instrument
Average
burden hours
per response
Total annual
burden hours
Semi-Structured Discussion and Information-Gathering Protocol ...................
600
1
.5
300
Estimated Total Annual Burden Hours .....................................................
........................
........................
........................
300
In compliance with the requirements
of Section 3506(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 Planning, Research and
Evaluation, 370 L’Enfant Promenade,
SW., Washington, DC 20447, Attn: ACF
Reports Clearance Officer. E-mail
address:
OPREinfocollection@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
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: March 31, 2008.
Brendan C. Kelly,
OPRE Reports Clearance Officer.
[FR Doc. E8–7139 Filed 4–7–08; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
pwalker on PROD1PC71 with NOTICES
[Docket No. FDA–2008–N–0172]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; New Animal Drugs
for Investigational Use
AGENCY:
Food and Drug Administration,
HHS.
VerDate Aug<31>2005
16:09 Apr 07, 2008
Jkt 214001
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the reporting and recordkeeping
requirements for ‘‘New Animal Drugs
for Investigational Use.’’
DATES: Submit written or electronic
comments on the collection of
information by June 9, 2008.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
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
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
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.
New Animal Drugs for Investigational
Use—21 CFR Part 511 (OMB Control
Number 0910–0117)—Extension
FDA has authority under the Federal
Food, Drug, and Cosmetic Act (the act)
to approve new animal drugs. Section
512(j) of the act (21 U.S.C 360b(j)),
authorized FDA to issue regulations for
the investigational use of new animal
drugs. The regulations which set forth
conditions for investigational use of
new animal drugs are codified under
part 511 (21 CFR part 511). If a new
animal drug is only for tests in vitro, or
testing in laboratory research animals,
the person distributing the new animal
drug must maintain records showing: (1)
The name and post office address of the
expert or expert organization to whom
the drug is shipped; and (2) the date,
quantity, batch or code mark for each
shipment for a period of 2 years after
such shipment or delivery. Prior to
shipping a new animal drug for clinical
investigations in animals, a sponsor
must submit to FDA a Notice of Claimed
Investigational Exemption (NCIE). The
NCIE must contain, among other things,
the following specific information: (1)
The identity of the new animal drug; (2)
labeling; (3) a statement of compliance
E:\FR\FM\08APN1.SGM
08APN1
19074
Federal Register / Vol. 73, No. 68 / Tuesday, April 8, 2008 / Notices
of any non-clinical laboratory studies
with good laboratory practices; (4) the
name and address of each clinical
investigator; (5) the approximate
number of animals to be treated or
amount of new animal drug(s) to be
shipped; and (6) information regarding
the use of edible tissues from
investigational animals. Part 511 also
requires that records be established and
maintained to document the
distribution and use of the
investigational drug to assure that its
use is safe and that the distribution is
controlled to prevent potential abuse.
The agency uses these required records
under its Bio-Research Monitoring
Program to monitor the validity of the
studies submitted to FDA to support
new animal drug approval and to assure
that proper use of the drug is
maintained by the investigator.
Investigational new animal drugs are
used primarily by the pharmaceutical
industry, academic institutions, and the
government. Investigators may include
individuals from these entities as well
as research firms and members of the
medical professional. Respondents for
this collection of information are
investigators who use new animal drugs
for investigational purposes.
FDA estimates the burden for this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
511.1(b)(4)
134
7.66
1,027
8
8,216
511.1(b)(5)
134
.19
25
140
3,500
511.1(b)(6)
134
.01
2
1
2
511.1(b)(8)(ii)
134
.11
15
20
300
511.1(b)(9)
134
6.7
20
8
160
Total
1 There
12,178
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
Annual Frequency
per
Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
511.1(a)(3)
134
2.96
400
9
3,600
511.1(b)(3)
134
7.66
1,027
1
1,027
511.1(b)(7)(ii)
134
7.46
1,000
3.5
3,500
511.1(b)(8)(i)
134
7.46
1,000
3.5
3,500
Total
pwalker on PROD1PC71 with NOTICES
1 There
11,627
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimates for reporting
requirements, record preparation, and
maintenance for this collection of
information are based on agency
communication with industry and
agency records. Based on the number of
sponsors subject to animal drug user
fees, FDA estimates there are 134
respondents. This estimate is used
consistently throughout the burden
tables and for example, the ‘‘annual
frequency per respondent’’ was
calculated by dividing the total annual
responses by the number of
respondents. Additional information
needed to make final calculations for
the total burden estimates in tables 1
and 2 of this document, i.e., the hours
per response, the hours per record, the
number of NCIEs received, etc., was
derived from agency records.
VerDate Aug<31>2005
16:09 Apr 07, 2008
Jkt 214001
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA through FDMS only.
Dated: March 31, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–7255 Filed 4–7–08; 8:45 am]
Frm 00028
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Food and Drug Administration
[Docket No. FDA–2008–D–0199] (formerly
Docket No. 2006D–0526)
International Conference on
Harmonisation; Guidance on E15
Pharmacogenomics Definitions and
Sample Coding; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance entitled ‘‘E15
Definitions for Genomic Biomarkers,
Pharmacogenomics, Pharmacogenetics,
Genomic Data and Sample Coding
Categories.’’ The guidance was prepared
BILLING CODE 4160–01–S
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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08APN1
]]>Agencies
[Federal Register Volume 73, Number 68 (Tuesday, April 8, 2008)]
[Notices]
[Pages 19073-19074]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-7255]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0172]
Agency Information Collection Activities; Proposed Collection;
Comment Request; New Animal Drugs for Investigational Use
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the reporting and
recordkeeping requirements for ``New Animal Drugs for Investigational
Use.''
DATES: Submit written or electronic comments on the collection of
information by June 9, 2008.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
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.
New Animal Drugs for Investigational Use--21 CFR Part 511 (OMB Control
Number 0910-0117)--Extension
FDA has authority under the Federal Food, Drug, and Cosmetic Act
(the act) to approve new animal drugs. Section 512(j) of the act (21
U.S.C 360b(j)), authorized FDA to issue regulations for the
investigational use of new animal drugs. The regulations which set
forth conditions for investigational use of new animal drugs are
codified under part 511 (21 CFR part 511). If a new animal drug is only
for tests in vitro, or testing in laboratory research animals, the
person distributing the new animal drug must maintain records showing:
(1) The name and post office address of the expert or expert
organization to whom the drug is shipped; and (2) the date, quantity,
batch or code mark for each shipment for a period of 2 years after such
shipment or delivery. Prior to shipping a new animal drug for clinical
investigations in animals, a sponsor must submit to FDA a Notice of
Claimed Investigational Exemption (NCIE). The NCIE must contain, among
other things, the following specific information: (1) The identity of
the new animal drug; (2) labeling; (3) a statement of compliance
[[Page 19074]]
of any non-clinical laboratory studies with good laboratory practices;
(4) the name and address of each clinical investigator; (5) the
approximate number of animals to be treated or amount of new animal
drug(s) to be shipped; and (6) information regarding the use of edible
tissues from investigational animals. Part 511 also requires that
records be established and maintained to document the distribution and
use of the investigational drug to assure that its use is safe and that
the distribution is controlled to prevent potential abuse. The agency
uses these required records under its Bio-Research Monitoring Program
to monitor the validity of the studies submitted to FDA to support new
animal drug approval and to assure that proper use of the drug is
maintained by the investigator.
Investigational new animal drugs are used primarily by the
pharmaceutical industry, academic institutions, and the government.
Investigators may include individuals from these entities as well as
research firms and members of the medical professional. Respondents for
this collection of information are investigators who use new animal
drugs for investigational purposes.
FDA estimates the burden for this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
511.1(b)(4) 134 7.66 1,027 8 8,216
----------------------------------------------------------------------------------------------------------------
511.1(b)(5) 134 .19 25 140 3,500
----------------------------------------------------------------------------------------------------------------
511.1(b)(6) 134 .01 2 1 2
----------------------------------------------------------------------------------------------------------------
511.1(b)(8)(ii) 134 .11 15 20 300
----------------------------------------------------------------------------------------------------------------
511.1(b)(9) 134 6.7 20 8 160
----------------------------------------------------------------------------------------------------------------
Total ................. ................. ................. ................. 12,178
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual Frequency
21 CFR Section No. of per Total Annual Hours per Record Total Hours
Recordkeepers Recordkeeping Records
----------------------------------------------------------------------------------------------------------------
511.1(a)(3) 134 2.96 400 9 3,600
----------------------------------------------------------------------------------------------------------------
511.1(b)(3) 134 7.66 1,027 1 1,027
----------------------------------------------------------------------------------------------------------------
511.1(b)(7)(ii) 134 7.46 1,000 3.5 3,500
----------------------------------------------------------------------------------------------------------------
511.1(b)(8)(i) 134 7.46 1,000 3.5 3,500
----------------------------------------------------------------------------------------------------------------
Total ................. ................. ................. ................. 11,627
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden estimates for reporting requirements, record
preparation, and maintenance for this collection of information are
based on agency communication with industry and agency records. Based
on the number of sponsors subject to animal drug user fees, FDA
estimates there are 134 respondents. This estimate is used consistently
throughout the burden tables and for example, the ``annual frequency
per respondent'' was calculated by dividing the total annual responses
by the number of respondents. Additional information needed to make
final calculations for the total burden estimates in tables 1 and 2 of
this document, i.e., the hours per response, the hours per record, the
number of NCIEs received, etc., was derived from agency records.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA
through FDMS only.
Dated: March 31, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-7255 Filed 4-7-08; 8:45 am]
BILLING CODE 4160-01-S
