Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How to Use E-Mail to Submit a Notice of Final Disposition of Animals Not Intended for Immediate Slaughter, 65827-65828 [E6-19044]
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65827
Federal Register / Vol. 71, No. 217 / Thursday, November 9, 2006 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0433]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on How to Use E–Mail to
Submit a Notice of Final Disposition of
Animals Not Intended for Immediate
Slaughter
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
extending the Office of Management and
Budget (OMB) approval on the existing
reporting requirements for the
information collection activity entitled
‘‘How to Use E–Mail to Submit a Notice
of Final Disposition of Animals Not
Intended for Immediate Slaughter.’’
DATES: Submit written or electronic
comments on the collection of
information by January 8, 2007.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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
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
SUPPLEMENTARY INFORMATION:
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.
Guidance for Industry on How to Use
E–Mail to Submit a Notice of Final
Disposition of Animals Not Intended for
Immediate Slaughter—21 CFR
514.117(b)(2) and 21 CFR 511.1(b)(5);
(OMB Control Number 0910–0453)—
Extension
The Center for Veterinary Medicine
(CVM) monitors the final disposition of
investigational animals where such
animals do not enter the human food
chain immediately at the completion of
the investigational study. CVM’s
monitoring of the final disposition of
investigational food animals is intended
to ensure that unsafe residues of new
animal drugs do not get into the food
supply. CVM issues a slaughter
authorization letter to investigational
new animal drug (INAD) sponsors that
sets the terms under which
investigational animals may be
slaughtered (21 CFR 511.1(b)(5)). Also
in this letter, CVM requests that
sponsors submit a notice of final
disposition of investigational animals
(NFDA) not intended for immediate
slaughter. NFDAs have historically been
submitted to CVM on paper. CVM’s
guidance ‘‘How to Use E–Mail to Submit
a Notice of Final Disposition of Animals
Not Intended for Immediate Slaughter’’
provides sponsors with the option to
submit an NFDA as an e-mail
attachment to CVM via the Internet.
The likely respondents are INAD
sponsors.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section/
Form No.
No. of
Respondents
511.1(b)(5)/Form FDA 3487
1
sroberts on PROD1PC70 with NOTICES
2
Annual Frequency
per Response
25
1.44
Hours per
Response
Total Annual
Responses2
36
.08
There are no capital costs or operating and maintenance costs associated with this collection of information.
Electronic submissions received between July 1, 2005, and June 30, 2006.
VerDate Aug<31>2005
16:26 Nov 08, 2006
Jkt 211001
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
E:\FR\FM\09NON1.SGM
Total Hours
09NON1
2.88
65828
Federal Register / Vol. 71, No. 217 / Thursday, November 9, 2006 / Notices
The number of respondents in table 1
are the number of sponsors registered to
make electronic submissions (25). The
number of total annual responses is
based on a review of the actual number
of such submissions made between July
1, 2005, and June 30, 2006 (36 x hours
per response (.08) = 2.88 total hours).
has submitted the following proposed
collection of information to OMB for
review and clearance.
Dated: November 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–19044 Filed 11–8–06; 8:45 am]
In accordance with section 513 of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360c), FDA
evaluated an application for an in vitro
diagnostic device for detection of
influenza subtype H5 (Asian lineage),
commonly known as avian flu. FDA
concluded that this device is properly
classified into class II in accordance
with section 513(a)(1)(B) of the act,
because it is a device for which the
general controls by themselves are
insufficient to provide reasonable
assurance of the safety and effectiveness
of the device, but there is sufficient
information to establish special controls
to provide such assurance. The statute
permits FDA to establish as special
controls many different things,
including postmarket surveillance,
development and dissemination of
guidance, recommendations, and ‘‘other
appropriate actions as the Secretary
deems necessary’’ (section 513(a)(1)(B)
of the act). This information collection
is a measure that FDA determined to be
necessary to provide reasonable
assurance of safety and effectiveness of
reagents for detection of specific novel
influenza A viruses.
FDA issued an order classifying the
H5 (Asian lineage) diagnostic device
into class II on February 3, 2006,
establishing the special controls
necessary to provide reasonable
assurance of the safety and effectiveness
of that device and similar future
devices. The new classification will be
codified in 21 CFR 866.3332, a
regulation that will describe the new
classification for reagents for detection
of specific novel influenza A viruses
and set forth the special controls that
help to provide a reasonable assurance
of the safety and effectiveness of devices
classified under that regulation. The
regulation will refer to the special
control guidance document, ‘‘Class II
Special Controls Guidance Document:
Reagents for Detection of Specific Novel
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0183]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance on
Reagents for Detection of Specific
Novel Influenza A Viruses
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 December
11, 2006.
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.
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.
In
compliance with 44 U.S.C. 3507, FDA
SUPPLEMENTARY INFORMATION:
Guidance on Reagents for Detection of
Specific Novel Influenza A Viruses—21
CFR 866.3332 (OMB Control Number
0910–0584)—Extension
Influenza A Viruses,’’ which provides
recommendations for measures to help
provide a reasonable assurance of safety
and effectiveness for these reagents.
The guidance document recommends
that sponsors obtain and analyze
postmarket data to ensure the continued
reliability of their device in detecting
the specific novel influenza A virus that
it is intended to detect, particularly
given the propensity for influenza
viruses to mutate and the potential for
changes in disease prevalence over time.
As updated sequences for novel
influenza A viruses become available
(from the World Health Organization,
National Institutes for Health, and other
public health entities), sponsors of
reagents for detection of specific novel
influenza A viruses will collect this
information, compare them with the
primer/probe sequences in their devices
and incorporate the result of these
analyses into their quality management
system, as required by 21 CFR
820.100(a)(1). These analyses will be
evaluated against the device design
validation and risk analysis required by
21 CFR 820.30(g), to determine if any
design changes may be necessary.
FDA considered comments expressed
by the Centers for Disease Control and
Prevention before the issuance of this
guidance.
FDA also published a notice in the
Federal Register of May 22, 2006 (71 FR
29342) soliciting comments on this
information collection as required under
5 CFR 1320.8(d). In response, FDA
received one comment concerning this
information collection. The comment
pointed out that the estimated hours per
response should be closer to 15, rather
than FDA’s estimate of 10 hours, in
order to comply with quality system
regulation/document control for the
new information collection. FDA agrees
with this comment and as a result, the
annual reporting burden hour estimate
has been recalculated accordingly, i.e.,
the total annual reporting burden hour
estimate is now 300 hours instead of
200.
Respondents to this collection of
information are manufacturers of in
vitro diagnostic devices.
FDA estimates the burden for this
collection of information as follows:
sroberts on PROD1PC70 with NOTICES
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN
No. of
Respondents
Annual Frequency
per Response
10
VerDate Aug<31>2005
Total Annual
Responses
2
16:26 Nov 08, 2006
Jkt 211001
PO 00000
Frm 00058
Hours per
Response
20
Fmt 4703
Sfmt 4703
Total Hours
15
E:\FR\FM\09NON1.SGM
300
09NON1
Total Operating
and
Maintenance
Costs
$3,500
]]>Agencies
[Federal Register Volume 71, Number 217 (Thursday, November 9, 2006)]
[Notices]
[Pages 65827-65828]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-19044]
[[Page 65827]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0433]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on How to Use E-Mail to Submit a
Notice of Final Disposition of Animals Not Intended for Immediate
Slaughter
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 extending the Office of
Management and Budget (OMB) approval on the existing reporting
requirements for the information collection activity entitled ``How to
Use E-Mail to Submit a Notice of Final Disposition of Animals Not
Intended for Immediate Slaughter.''
DATES: Submit written or electronic comments on the collection of
information by January 8, 2007.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. 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 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.
Guidance for Industry on How to Use E-Mail to Submit a Notice of Final
Disposition of Animals Not Intended for Immediate Slaughter--21 CFR
514.117(b)(2) and 21 CFR 511.1(b)(5); (OMB Control Number 0910-0453)--
Extension
The Center for Veterinary Medicine (CVM) monitors the final
disposition of investigational animals where such animals do not enter
the human food chain immediately at the completion of the
investigational study. CVM's monitoring of the final disposition of
investigational food animals is intended to ensure that unsafe residues
of new animal drugs do not get into the food supply. CVM issues a
slaughter authorization letter to investigational new animal drug
(INAD) sponsors that sets the terms under which investigational animals
may be slaughtered (21 CFR 511.1(b)(5)). Also in this letter, CVM
requests that sponsors submit a notice of final disposition of
investigational animals (NFDA) not intended for immediate slaughter.
NFDAs have historically been submitted to CVM on paper. CVM's guidance
``How to Use E-Mail to Submit a Notice of Final Disposition of Animals
Not Intended for Immediate Slaughter'' provides sponsors with the
option to submit an NFDA as an e-mail attachment to CVM via the
Internet.
The likely respondents are INAD sponsors.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
21 CFR Section/ No. of Annual Frequency Total Annual Hours per
Form No. Respondents per Response Responses\2\ Response Total Hours
----------------------------------------------------------------------------------------------------------------
511.1(b)(5)/Form 25 1.44 36 .08 2.88
FDA 3487
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Electronic submissions received between July 1, 2005, and June 30, 2006.
[[Page 65828]]
The number of respondents in table 1 are the number of sponsors
registered to make electronic submissions (25). The number of total
annual responses is based on a review of the actual number of such
submissions made between July 1, 2005, and June 30, 2006 (36 x hours
per response (.08) = 2.88 total hours).
Dated: November 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-19044 Filed 11-8-06; 8:45 am]
BILLING CODE 4160-01-S
