Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals, 31693-31694 [E8-12302]
Download as PDF
31693
Federal Register / Vol. 73, No. 107 / Tuesday, June 3, 2008 / Notices
and Cosmetic Act by adding subsection
(g) (21 U.S.C. 374 (g)). This amendment
authorized FDA to establish a voluntary
third party inspection program
applicable to manufacturers of class II or
class III medical devices who meet
certain eligibility criteria. On September
15, 2005, FDA issued a guidance
entitled, ‘‘Requests for Inspection by an
Accredited Person under the Inspection
by Accredited Persons Program
Authorized by Section 201 of the
Medical Device User Fee and
Modernization Act 2002,’’ https://
www.fda.gov/cdrh/comp/guidance/
1532.html. This guidance describes the
eligibility criteria and the process for
establishments to follow when
requesting FDA’s approval to have an
accredited person (AP) conduct a
quality system regulation inspection of
their establishment under the new
inspection by the Accredited Persons
Program (AP program) instead of FDA.
The AP program applies to
manufacturers who currently market
their medical devices in the United
States and who also market or plan to
market their devices in foreign
countries. Such manufacturers may
need current inspections of their
establishments to operate in global
commerce.
In order to meet the eligibility criteria
for requesting FDA approval to have an
AP conduct a quality system regulations
inspection of their establishment
instead of FDA, applicants must submit
a request with certain information. The
following information must be
submitted, which shows that the
applicant:
(1) ‘‘Manufactures, prepares,
propagates, compounds, or processes’’
class II or class III medical devices,
(2) Markets at least one of the devices
in the United States,
(3) Markets or intends to market at
least one of the devices in one or more
foreign countries when one or both of
the following two conditions are met:
(a) One of the foreign countries
certifies, accredits, or otherwise
recognizes the selected AP applicant as
a person authorized to conduct
inspections of device establishments, or
(b) A statement that the law of a
country where the applicant markets or
intends to market the device recognizes
an inspection conducted by FDA or an
AP.
(4) Provided the most recent
inspection performed by FDA, or by an
AP under the AP program and
inspection was classified by FDA as
either ‘‘No Action Indicated’’ or
‘‘Voluntary Action Indicated’’ and,
(5) Provided notice advising FDA of
their intent to use an AP, and
identifying the AP applicant selected.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 U.S.C. Section:
No. of
Respondents
374(g)
ebenthall on PRODPC60 with NOTICES
1 There
Annual Frequency
per Response
100
Total Annual
Responses
1
Hours per
Response
100
Total Hours
15
1,500
are no capital costs or operating and maintenance costs associated with this collection of information.
There are approximately 8,000 foreign
and 10,000 domestic manufacturers of
medical devices. Approximately 5,000
of these firms only manufacture class I
devices and are, therefore, not eligible
for the AP program. In addition, 40
percent of the domestic firms do not
export devices and therefore are not
eligible to participate in the AP
program. Further, 10 to 15 percent of the
firms are not eligible due to the results
of their previous inspection. FDA
estimates there are 4,000 domestic
manufacturers and 4,000 foreign
manufacturers that are eligible for
inclusion under the AP program. Based
on communications with industry, FDA
estimates that on an annual basis
approximately 100 of these
manufacturers may submit a request to
use an AP in any given year.
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 only through FDMS at
https://www.regulations.gov.
VerDate Aug<31>2005
14:18 Jun 02, 2008
Jkt 214001
Dated: May 27, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–12297 Filed 6–2–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0312]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Extralabel Drug
Use in Animals
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
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
public comment in response to the
notice. This notice solicits comments on
the reporting requirements associated
with extralabel drug use in animals.
DATES: Submit written or electronic
comments on the collection of
information by August 4, 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.
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\03JNN1.SGM
03JNN1
31694
Federal Register / Vol. 73, No. 107 / Tuesday, June 3, 2008 / Notices
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.
Extralabel Drug Use in Animals—21
CFR Part 530 (OMB Control Number
0910–0325—Extension)
Under part 530 (21 CFR Part 530), a
veterinarian is permitted to prescribe
the extralabel use of approved new
animal drugs. Section 530.22 (b) of the
implementing regulations permits FDA,
if it finds there is a reasonable
probability that the extralabel use of an
animal drug may present a risk to the
public health, to: (1) Establish a safe
level for a residue from the extralabel
use of the drug, and (2) require the
development of an analytical method for
the detection of residues above that
established safe level. To date, FDA has
not established a safe level for a residue
from the extralabel use of any new
animal drug and therefore has not
required the development of analytical
methodology. However, the agency
believes that there may be instances
when analytical methodology will be
required. Thus, FDA is estimating the
reporting burden based on two methods
being required annually. The
requirement to establish an analytical
method may be fulfilled by any
interested person. The agency believes
that the sponsor of the drug will be
willing to develop the method in most
cases. Alternatively, FDA, the sponsor,
and perhaps a third party may
cooperatively arrange for method
development. The respondents may be
sponsors of new animal drugs, State, or
Federal government, or individuals.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
530.22(b)
1 There
Annual Frequency
per Response
2
1
Hours per
Response
2
Total Hours
4,160
8,320
are no capital costs or operating and maintenance costs associated with this collection of information.
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 only through FDMS at
https://www.regulations.gov.
Dated: May 27, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–12302 Filed 6–2–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0129]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food Canning
Establishment Registration, Process
Filing, and Recordkeeping for Acidified
Foods and Thermally Processed LowAcid Foods in Hermetically Sealed
Containers
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
ebenthall on PRODPC60 with NOTICES
Total Annual
Responses
To ensure that comments on
the information collection are received,
OMB recommends that written
ADDRESSES:
14:18 Jun 02, 2008
Jkt 214001
PO 00000
Frm 00022
Fmt 4703
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
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:
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 3,
2008.
VerDate Aug<31>2005
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 0910–0037. Also
include the FDA docket number found
in brackets in the heading of this
document.
Sfmt 4703
Food Canning Establishment
Registration, Process Filing, and
Recordkeeping for Acidified Foods and
Thermally Processed Low-Acid Foods
in Hermetically Sealed Containers—
(OMB Control Number 0910–0037)—
Extension
Under the Federal Food, Drug, and
Cosmetic Act (the act), FDA is
authorized to prevent the interstate
E:\FR\FM\03JNN1.SGM
03JNN1
Agencies
[Federal Register Volume 73, Number 107 (Tuesday, June 3, 2008)]
[Notices]
[Pages 31693-31694]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-12302]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0312]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Extralabel Drug Use in Animals
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 requirements
associated with extralabel drug use in animals.
DATES: Submit written or electronic comments on the collection of
information by August 4, 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
[[Page 31694]]
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.
Extralabel Drug Use in Animals--21 CFR Part 530 (OMB Control Number
0910-0325--Extension)
Under part 530 (21 CFR Part 530), a veterinarian is permitted to
prescribe the extralabel use of approved new animal drugs. Section
530.22 (b) of the implementing regulations permits FDA, if it finds
there is a reasonable probability that the extralabel use of an animal
drug may present a risk to the public health, to: (1) Establish a safe
level for a residue from the extralabel use of the drug, and (2)
require the development of an analytical method for the detection of
residues above that established safe level. To date, FDA has not
established a safe level for a residue from the extralabel use of any
new animal drug and therefore has not required the development of
analytical methodology. However, the agency believes that there may be
instances when analytical methodology will be required. Thus, FDA is
estimating the reporting burden based on two methods being required
annually. The requirement to establish an analytical method may be
fulfilled by any interested person. The agency believes that the
sponsor of the drug will be willing to develop the method in most
cases. Alternatively, FDA, the sponsor, and perhaps a third party may
cooperatively arrange for method development. The respondents may be
sponsors of new animal drugs, State, or Federal government, or
individuals.
FDA estimates the burden of 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
----------------------------------------------------------------------------------------------------------------
530.22(b) 2 1 2 4,160 8,320
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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 only
through FDMS at https://www.regulations.gov.
Dated: May 27, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-12302 Filed 6-2-08; 8:45 am]
BILLING CODE 4160-01-S