Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization, 7276-7277 [2010-3027]
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7276
Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices
concluding that foods containing the
expression products can be safely
consumed;
• Information comparing the
composition or characteristics of the
bioengineered food to that of food
derived from the parental variety or
other commonly consumed varieties of
the same crop with special emphasis on
important nutrients, and toxicants that
occur naturally in the food;
• A discussion of the available
information that addresses whether the
potential for the food derived from a
bioengineered plant to induce an
allergic response has been altered by the
genetic modification; and
• Any other information relevant to
the safety and nutritional assessment of
the bioengineered food.
In 2001, FDA contacted 5 firms that
had made 1 or more biotechnology
consultation submissions under the
1996 procedures. FDA asked each of
these firms for an estimate of the hourly
burden to prepare a submission under
the voluntary biotechnology
consultation process. Three of these
firms subsequently provided the
requested information. Based on this
information, FDA estimated that the
average time to prepare a submission for
final consultation under the 1996
procedures is 150 hours (69 FR 68379 at
68381). The availability of the form, and
the opportunity to provide the
information in electronic format, could
reduce this estimate. However, as a
conservative approach for the purpose
of this analysis, FDA is assuming that
the availability of the form and the
opportunity to submit the information
in electronic format will have no effect
on the average time to prepare a
submission for final consultation under
the 1996 procedures.
Dated: February 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–3028 Filed 2–17–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
[Docket No. FDA–2010–N–0070]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Agreement for
Shipment of Devices for Sterilization
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Nov<24>2008
16:37 Feb 17, 2010
Jkt 220001
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
information collection requirements
relating to shipment of nonsterile
devices that are to be sterilized
elsewhere or are shipped to other
establishments for further processing,
labeling, or repacking.
DATES: Submit written or electronic
comments on the collection of
information by April 19, 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:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
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
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
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.
Agreement for Shipment of Devices for
Sterilization—21 CFR 801.150(e) (OMB
Control Number 0910–0131)—Extension
Under sections 501(c) and 502(a) of
the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 351(c) and
352(a)), nonsterile devices that are
labeled as sterile but are in interstate
transit to a facility to be sterilized are
adulterated and misbranded. FDA
regulations in § 801.150(e) (21 CFR
801.150(e)) establish a control
mechanism by which firms may
manufacture and label medical devices
as sterile at one establishment and ship
the devices in interstate commerce for
sterilization at another establishment, a
practice that facilitates the processing of
devices and is economically necessary
for some firms. Under § 801.150(e)(1),
manufacturers and sterilizers may sign
an agreement containing the following:
(1) Instructions for maintaining
accountability of the number of units in
each shipment; (2) acknowledgment that
the devices that are nonsterile are being
shipped for further processing; and (3)
specifications for sterilization
processing.
This agreement allows the
manufacturer to ship misbranded
products to be sterilized without
initiating regulatory action and provides
FDA with a means to protect consumers
from use of nonsterile products.
During routine plant inspections, FDA
normally reviews agreements that must
be kept for 2 years after final shipment
or delivery of devices (§ 801.150(a)(2)).
The respondents to this collection of
information are device manufacturers
and contact sterilizers.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\18FEN1.SGM
18FEN1
7277
Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
801.150(e)
1 There
90
Total Annual
Responses
20
Hours per
Response
1,800
Total Hours
4
7,200
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
801.150(a)(2)
1 There
Annual Frequency
per Recordkeeping
90
20
Hours per
Record
1,800
Total Operating &
Maintenance Costs
Total Hours
0.5
900
$55,800
are no capital costs associated with this collection of information.
FDA’s estimate of the reporting
burden is based on actual data obtained
from industry over the past several years
where there are approximately 90 firms
subject to this requirement. It is
estimated that each of these firms on the
average prepares 20 written agreements
each year. This estimate varies greatly,
from 1 to 100, because some firms
provide sterilization services on a part
time basis for only one customer while
others are large facilities with many
customers. The average time required to
prepare each written agreement is
estimated to be four hours. This
estimate varies depending on whether
the agreement is the initial agreement or
an annual renewal, on the format each
firm elects to use, and on the length of
time required to reach agreement. The
estimate applies only to those portions
of the written agreement that pertain to
the requirements imposed by this
regulation. The written agreement
generally also includes contractual
agreements that are a customary and
usual business practice. On the average,
the total annual recordkeeping burden is
7,200 hours (90 firms x 20 agreements
x 4 hours).
The recordkeeping requirements of
§ 801.150(a)(2) consist of making copies
and maintaining the actual reporting
requests which were required under the
reporting section of this collection. To
fulfill this requirement, FDA estimates it
will take about 30 minutes to copy each
package, for a total of 900 recordkeeping
hours and includes $55,800 operating
and maintenance costs.
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Total Annual
Records
Dated: February 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–3027 Filed 2–17–10; 8:45 am]
BILLING CODE 4160–01–S
VerDate Nov<24>2008
16:37 Feb 17, 2010
Jkt 220001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0055]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on How to Submit a Protocol
Without Data 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
‘‘Guidance for Industry on How to
Submit a Protocol Without Data in
Electronic Format to the Center for
Veterinary Medicine.’’
DATES: Submit written or electronic
comments on the collection of
information by April 19, 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
Frm 00047
Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of the
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:
E:\FR\FM\18FEN1.SGM
18FEN1
Agencies
[Federal Register Volume 75, Number 32 (Thursday, February 18, 2010)]
[Notices]
[Pages 7276-7277]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3027]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0070]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Agreement for Shipment of Devices for Sterilization
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 information collection
requirements relating to shipment of nonsterile devices that are to be
sterilized elsewhere or are shipped to other establishments for further
processing, labeling, or repacking.
DATES: Submit written or electronic comments on the collection of
information by April 19, 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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
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.
Agreement for Shipment of Devices for Sterilization--21 CFR 801.150(e)
(OMB Control Number 0910-0131)--Extension
Under sections 501(c) and 502(a) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 351(c) and 352(a)), nonsterile
devices that are labeled as sterile but are in interstate transit to a
facility to be sterilized are adulterated and misbranded. FDA
regulations in Sec. 801.150(e) (21 CFR 801.150(e)) establish a control
mechanism by which firms may manufacture and label medical devices as
sterile at one establishment and ship the devices in interstate
commerce for sterilization at another establishment, a practice that
facilitates the processing of devices and is economically necessary for
some firms. Under Sec. 801.150(e)(1), manufacturers and sterilizers
may sign an agreement containing the following: (1) Instructions for
maintaining accountability of the number of units in each shipment; (2)
acknowledgment that the devices that are nonsterile are being shipped
for further processing; and (3) specifications for sterilization
processing.
This agreement allows the manufacturer to ship misbranded products
to be sterilized without initiating regulatory action and provides FDA
with a means to protect consumers from use of nonsterile products.
During routine plant inspections, FDA normally reviews agreements
that must be kept for 2 years after final shipment or delivery of
devices (Sec. 801.150(a)(2)).
The respondents to this collection of information are device
manufacturers and contact sterilizers.
FDA estimates the burden of this collection of information as
follows:
[[Page 7277]]
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
----------------------------------------------------------------------------------------------------------------
801.150(e) 90 20 1,800 4 7,200
----------------------------------------------------------------------------------------------------------------
\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 Total Operating &
21 CFR Section Recordkeepers per Recordkeeping Records Record Total Hours Maintenance Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.150(a)(2) 90 20 1,800 0.5 900 $55,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.
FDA's estimate of the reporting burden is based on actual data
obtained from industry over the past several years where there are
approximately 90 firms subject to this requirement. It is estimated
that each of these firms on the average prepares 20 written agreements
each year. This estimate varies greatly, from 1 to 100, because some
firms provide sterilization services on a part time basis for only one
customer while others are large facilities with many customers. The
average time required to prepare each written agreement is estimated to
be four hours. This estimate varies depending on whether the agreement
is the initial agreement or an annual renewal, on the format each firm
elects to use, and on the length of time required to reach agreement.
The estimate applies only to those portions of the written agreement
that pertain to the requirements imposed by this regulation. The
written agreement generally also includes contractual agreements that
are a customary and usual business practice. On the average, the total
annual recordkeeping burden is 7,200 hours (90 firms x 20 agreements x
4 hours).
The recordkeeping requirements of Sec. 801.150(a)(2) consist of
making copies and maintaining the actual reporting requests which were
required under the reporting section of this collection. To fulfill
this requirement, FDA estimates it will take about 30 minutes to copy
each package, for a total of 900 recordkeeping hours and includes
$55,800 operating and maintenance costs.
Dated: February 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3027 Filed 2-17-10; 8:45 am]
BILLING CODE 4160-01-S