Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How to Submit a Notice of Final Disposition of Investigational Animals Not Intended for Immediate Slaughter in Electronic Format to the Center for Veterinary Medicine, 6037-6038 [2010-2527]
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6037
Federal Register / Vol. 75, No. 24 / Friday, February 5, 2010 / Notices
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
Annual Frequency
per Recordkeeping
Total Annual
Record
Hours per
Records
Total Hours
822.31
21
1
21
20
420
822.32
63
1
63
10
630
Total
1 There
1,050
are no capital costs or operating and maintenance costs associated with this collection of information.
Explanation of Reporting Burden
Estimate
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The burden captured in table 1 for
this document for each of these
responses is based on the data available
in FDA’s internal tracking system for
2009. There was not an internal tracking
system prior to 2009.
Sections 822.26, 822.27, and 822.34
do not constitute information collection
subject to review under the PRA
because ‘‘it entails no burden other than
that necessary to identify the
respondent, the date, the respondent’s
address, and the nature of the
instrument.’’ (5 CFR 1320.3(h)(1)).
Food and Drug Administration
Explanation of Recordkeeping Burden
Estimate
srobinson on DSKHWCL6B1PROD with NOTICES
FDA expects that at least some of the
manufacturers will be able to satisfy the
PS requirement using information or
data they already have. For purposes of
calculating burden, however, FDA has
assumed that each PS order can only be
satisfied by a 3-year clinically-based
surveillance plan, using three
investigators. These estimates are based
on FDA’s knowledge and experience
with limited implementation of section
522 under the Safe Medical Devices Act.
Therefore, FDA would expect that the
recordkeeping requirements would
apply to a maximum of 21
manufacturers (3 to 4 added each year)
and 30 investigators (3 per surveillance
plan). After 3 years, FDA would expect
these numbers to remain level as the
surveillance plans conducted under the
earliest orders reach completion and
new orders are issued.
Dated: January 27, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–2458 Filed 2–4–10; 8:45 am]
BILLING CODE 4160–01–S
VerDate Nov<24>2008
16:26 Feb 04, 2010
Jkt 220001
[Docket No. FDA–2010–D–0034]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on How to Submit a Notice of
Final Disposition of Investigational
Animals Not Intended for Immediate
Slaughter in Electronic Format to the
Center for Veterinary Medicine
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 for the
information collection activity ‘‘How to
Submit a Notice of Final Disposition of
Investigational Animals Not Intended
for Immediate Slaughter In Electronic
Format to the Center for Veterinary
Medicine.’’
DATES: Submit written or electronic
comments on the collection of
information by April 6, 2010.
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.
PO 00000
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Fmt 4703
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FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
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.
SUPPLEMENTARY INFORMATION:
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05FEN1
6038
Federal Register / Vol. 75, No. 24 / Friday, February 5, 2010 / Notices
Guidance for Industry on How to
Submit a Notice of Final Disposition of
Investigational Animals Not Intended
for Immediate Slaughter in Electronic
Format to the Center for Veterinary
Medicine—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
an 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 the 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
entitled ‘‘How to Submit a Notice of
Final Disposition of Investigational
Animals Not Intended for Immediate
Slaughter in Electronic Format to CVM,’’
provides sponsors with an 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. 3487
No. of
Respondents
511.1(b)(5)
1 There
Annual Frequency
per Response
40
Total Annual
Responses2
0.4
Hours per
Response
16
Total Hours
.08
1.3
are no capital costs or operating and maintenance costs associated with this collection of information.
submissions received between January 1, 2008, and December 31, 2008.
2 Electronic
The number of respondents in table 1
of this document are the number of
sponsors registered to make electronic
submissions (40). The number of total
annual responses is based on a review
of the actual number of such
submissions made between January 1,
2008, and December 31, 2008. Thus,
FDA estimates the total reporting
burden at 1.3 hours (16 x .08 = 1.3 total
hours).
Dated: January 29, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–2527 Filed 2–4–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0057]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on How to Submit Information
in Electronic Format to the Center for
Veterinary Medicine Using the Food
and Drug Administration Electronic
Submission Gateway
srobinson on DSKHWCL6B1PROD with NOTICES
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
VerDate Nov<24>2008
16:26 Feb 04, 2010
Jkt 220001
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 for the
Center for Veterinary Medicine’s
(CVM’s) ‘‘Guidance for Industry on How
to Submit Information in Electronic
Format to the Center for Veterinary
Medicine Using the FDA Electronic
Gateway.’’
DATES: Submit written or electronic
comments on the collection of
information by April 6, 2010.
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
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–796–3793.
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
PO 00000
Frm 00099
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\05FEN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 24 (Friday, February 5, 2010)]
[Notices]
[Pages 6037-6038]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-2527]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0034]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on How to Submit a Notice of
Final Disposition of Investigational Animals Not Intended for Immediate
Slaughter in Electronic Format to the Center for Veterinary Medicine
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 for
the information collection activity ``How to Submit a Notice of Final
Disposition of Investigational Animals Not Intended for Immediate
Slaughter In Electronic Format to the Center for Veterinary Medicine.''
DATES: Submit written or electronic comments on the collection of
information by April 6, 2010.
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
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
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.
[[Page 6038]]
Guidance for Industry on How to Submit a Notice of Final Disposition of
Investigational Animals Not Intended for Immediate Slaughter in
Electronic Format to the Center for Veterinary Medicine--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 an
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 the 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
entitled ``How to Submit a Notice of Final Disposition of
Investigational Animals Not Intended for Immediate Slaughter in
Electronic Format to CVM,'' provides sponsors with an 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. 3487 Respondents per Response Responses\2\ Response Total Hours
----------------------------------------------------------------------------------------------------------------
511.1(b)(5) 40 0.4 16 .08 1.3
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Electronic submissions received between January 1, 2008, and December 31, 2008.
The number of respondents in table 1 of this document are the
number of sponsors registered to make electronic submissions (40). The
number of total annual responses is based on a review of the actual
number of such submissions made between January 1, 2008, and December
31, 2008. Thus, FDA estimates the total reporting burden at 1.3 hours
(16 x .08 = 1.3 total hours).
Dated: January 29, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-2527 Filed 2-4-10; 8:45 am]
BILLING CODE 4160-01-S
