Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Investigational Use, 36533-36534 [E8-14653]
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36533
Federal Register / Vol. 73, No. 125 / Friday, June 27, 2008 / Notices
Dated: June 20, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–14535 Filed 6–26–08; 8:45 am]
BILLING CODE 4160–01–S
Food and Drug Administration
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:
[Docket No. FDA–2008–N–0172]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; New Animal Drugs
for Investigational Use
Food and Drug Administration,
HHS.
ACTION:
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
control number 0910–0117. Also
include the FDA docket number found
in brackets in the heading of this
document.
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 July 28,
2008.
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
baguilar@omb.eop.gov. All comments
should be identified with the OMB
New Animal Drugs for Investigational
Use (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
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 to
this collection of information are
investigators who use new animal drugs
for investigational purposes.
In the Federal Register of April 8,
2008 (73 FR 19073), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
511.1(b)(4)
134
7.66
1027
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
20
8
160
6.7
Total
1 There
12,178
are no capital costs or operating and maintenance costs associated with this collection of information.
jlentini on PROD1PC65 with NOTICES
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Recordkeeper
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
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18:47 Jun 26, 2008
Jkt 214001
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Fmt 4703
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36534
Federal Register / Vol. 73, No. 125 / Friday, June 27, 2008 / Notices
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued
No. of
Recordkeepers
21 CFR Section
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Recordkeeper
Total Hours
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. Based on
the number of sponsors subject to
animal drug user fees, FDA estimates
that there are 134 respondents. We use
this estimate consistently throughout
the table and calculated the ‘‘annual
frequency per respondent’’ by dividing
the total annual responses by number of
respondents. Additional information
needed to make final calculations of the
total burden hours i.e., the number of
respondents, the number of record
keepers, the number of NCIEs received,
etc., was derived from agency records.
Dated: June 23, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–14653 Filed 6–26–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0227]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
Labeling Regulations
AGENCY:
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with NOTICES
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 July 28,
2008.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
VerDate Aug<31>2005
18:47 Jun 26, 2008
Jkt 214001
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0485. Also
include the FDA 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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Medical Device Labeling Regulations—
(OMB Control Number 0910–0485)—
Extension
Section 502 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
352), among other things, establishes
requirements for the label or labeling of
a medical device so that it is not
misbranded and subject to a regulatory
action. Certain provisions under section
502 of the act require manufacturers,
importers, and distributors of medical
devices to disclose information about
themselves or the devices, on the labels
or labeling for the devices. Section
502(b) of the act requires that for
packaged devices, the label must bear
the name and place of business of the
manufacturer, packer, or distributor as
well as an accurate statement of the
quantity of the contents. Section 502(f)
of the act requires that the labeling for
a device must contain adequate
directions for use. FDA may however,
grant an exemption, if the agency
determines that the adequate directions
for use labeling requirements are not
necessary for the particular case, as it
relates to protection of the public
health.
FDA regulations under parts 800, 801,
and 809 (21 CFR parts 800, 801, and
809) require disclosure of specific
information by manufacturers,
importers, and distributors of medical
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
devices about themselves or the devices,
on the label or labeling for the devices
to health professionals and consumers.
FDA issued these regulations under the
authority of sections 201, 301, 502, and
701 of the act (21 U.S.C. 321, 331, 352,
and 371). Most of the regulations under
parts 800, 801, and 809 are derived from
requirements of section 502 of the act,
which provides in part, that a device
shall be misbranded if among other
things, its label or labeling fails to bear
certain required information concerning
the device, is false or misleading in any
particular way, or fails to contain
adequate directions for use.
Reporting Burden
Sections 800.10(a)(3) and 800.12(c)
require that the label for contact lens
cleaning solutions bear a prominent
statement alerting consumers of the
tamper-resistant feature. Further,
§ 800.12 requires that packaged contact
lens cleaning solutions contain a
tamper-resistant feature, to prevent
malicious adulteration.
Section 800.10(b)(2) requires that the
labeling for liquid ophthalmic
preparations packed in multiple-dose
containers provide information on the
duration of use and the necessary
warning information to afford adequate
protection from contamination during
use.
Section 801.1 requires that the label
for a device in package form, contain the
name and place of business of the
manufacturer, packer, or distributor.
Section 801.5 requires that labeling
for a device include information on
intended use as defined under § 801.4
and provide adequate directions to
assure safe use by the lay consumers.
Section 801.61 requires that the
principal display panel of an over-thecounter (OTC) device in package form
must bear a statement of the identity of
the device. The statement of identity of
the device must include the common
name of the device followed by an
accurate statement of the principal
intended actions of the device.
Section 801.62 requires that the label
for an OTC device in package form,
must bear a statement of declaration of
the net quantity of contents. The label
E:\FR\FM\27JNN1.SGM
27JNN1
]]>Agencies
[Federal Register Volume 73, Number 125 (Friday, June 27, 2008)]
[Notices]
[Pages 36533-36534]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-14653]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0172]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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 July
28, 2008.
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 baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0117. Also
include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
New Animal Drugs for Investigational Use (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 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 to
this collection of information are investigators who use new animal
drugs for investigational purposes.
In the Federal Register of April 8, 2008 (73 FR 19073), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
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 1027 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) 134 .11 15 20 300
(ii)
----------------------------------------------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers per Recordkeeping Records Recordkeeper 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
----------------------------------------------------------------------------------------------------------------
[[Page 36534]]
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. Based on the number of
sponsors subject to animal drug user fees, FDA estimates that there are
134 respondents. We use this estimate consistently throughout the table
and calculated the ``annual frequency per respondent'' by dividing the
total annual responses by number of respondents. Additional information
needed to make final calculations of the total burden hours i.e., the
number of respondents, the number of record keepers, the number of
NCIEs received, etc., was derived from agency records.
Dated: June 23, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14653 Filed 6-26-08; 8:45 am]
BILLING CODE 4160-01-S
