Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization, 20658-20660 [2013-07916]
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20658
Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Notices
Appendix E—LGBTQ Accessibility
Policy
As the Authorized Organizational
Representative (AOR) signing this
application on behalf of [Insert full, formal
name of applicant organization]
I hereby attest and certify that:
The needs of lesbian, gay, bisexual,
transgender, and questioning people are
taken into consideration in applicant’s
programming. Applicant has considered how
its programming will be inclusive of and
non-stigmatizing toward such individuals. If
not already in place, awardee must establish
and publicize policies prohibiting
harassment based on race, sexual orientation,
gender, gender identity (or expression),
religion, and national origin. The submission
of an application for this funding opportunity
constitutes an assurance that applicant has or
will put such policies in place within 12
months of the award. Awardees should
ensure that all staff members are trained to
prevent and respond to harassment or
bullying in all forms during the award
period. Within 12 months of the award
awardee must be prepared to monitor claims,
address them seriously, and document their
corrective action(s) so all programming
beneficiaries are assured that the applicant
organization and its programming is safe,
inclusive, and non-stigmatizing by design
and in operation.
Insert Date of Signature:
Print Name and Title of the AOR:
Signature of AOR:
[FR Doc. 2013–08027 Filed 04/04/
2013 at 8:45 a.m.]
[FR Doc. 2013–08027 Filed 4–4–13; 8:45 am]
BILLING CODE 4184–32–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Tribal Consultation Meeting
Administration for Children
and Families’ Office of Head Start
(OHS), HHS.
ACTION: Notice of meeting.
AGENCY:
Pursuant to the Improving
Head Start for School Readiness Act of
2007, Public Law 110–134, notice is
hereby given of two 1-day Tribal
Consultation Sessions to be held
between the Department of Health and
Human Services, Administration for
Children and Families, Office of Head
Start leadership and the leadership of
Tribal Governments operating Head
Start (including Early Head Start)
programs. The purpose of these
Consultation Sessions is to discuss ways
to better meet the needs of American
Indian and Alaska Native children and
their families, taking into consideration
funding allocations, distribution
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SUMMARY:
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formulas, and other issues affecting the
delivery of Head Start services in their
geographic locations [42 U.S.C. 9835,
640(l)(4)].
May 9, 2013, and July 26, 2013.
2013 Office of Head Start
Tribal Consultation Sessions will be
held at the following locations:
Thursday, May 9, 2013—Green Bay,
Wisconsin—Radisson Hotel &
Conference Center, 2040 Airport
Drive, Green Bay, WI 54313; and
Friday, July 26, 2013—Tulsa,
Oklahoma—Renaissance Tulsa Hotel
& Convention Center, 6808 S. 107th
East Avenue, Tulsa, OK 74133
FOR FURTHER INFORMATION CONTACT:
Robert Bialas, Regional Program
Manager, Region XI, Office of Head
Start, email Robert.Bialas@acf.hhs.gov
or phone (202) 205–9497. Additional
information and online meeting
registration is available at https://
eclkc.ohs.acf.hhs.gov/hslc/
eclkc_main_calendar/tc-2013.
SUPPLEMENTARY INFORMATION: The
Department of Health and Human
Services (HHS) announces Office of
Head Start (OHS) Tribal Consultations
for leaders of Tribal Governments
operating Head Start and Early Head
Start programs. As much as possible, the
OHS Tribal Consultations are being
scheduled in conjunction with other
tribal events. The Consultation in Tulsa
will be held in conjunction with the
Oklahoma Indian Head Start Directors
Association (OIHSDA) Conference. Such
scheduling is an effort to minimize the
burden of travel for tribal participants.
Tribal Consultation dates and locations
for other parts of the country, including
Alaska, will be announced at a later
date.
The agenda for the scheduled OHS
Tribal Consultations will be organized
around the statutory purposes of Head
Start Tribal Consultations related to
meeting the needs of American Indian/
Alaska Native children and families,
taking into consideration funding
allocations, distribution formulas, and
other issues affecting the delivery of
Head Start services in their geographic
locations. In addition, OHS will share
actions taken and in progress to address
the issues and concerns raised in 2012
OHS Tribal Consultations.
Tribal leaders and designated
representatives interested in submitting
written testimony or proposing specific
agenda topics for these Consultation
Sessions should contact Robert Bialas at
Robert.Bialas@acf.hhs.gov. Proposals
must be submitted at least 3 days in
advance of each session and should
include a brief description of the topic
DATES:
ADDRESSES:
PO 00000
Frm 00047
Fmt 4703
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area, along with the name and contact
information of the suggested presenter.
The Consultation Session will be
conducted with elected or appointed
leaders of Tribal Governments and their
designated representatives [42 U.S.C.
9835, 640(l)(4)(A)]. Designees must have
a letter from the Tribal Government
authorizing them to represent the tribe.
The letter should be submitted at least
3 days in advance of the Consultation
Session to Robert Bialas via fax at 866–
396–8843. Other representatives of
tribal organizations and Native
nonprofit organizations are welcome to
attend as observers.
A detailed report of the Consultation
Session will be prepared and made
available within 45 days of the
Consultation Session to all Tribal
Governments receiving funds for Head
Start and Early Head Start programs.
Tribes wishing to submit written
testimony for the report should send
testimony to Robert Bialas at
Robert.Bialas@acf.hhs.gov either prior
to the Consultation Session or within 30
days after the meeting.
Oral testimony and comments from
the Consultation Session will be
summarized in each report without
attribution, along with topics of concern
and recommendations. Hotel and
logistical information for the
Consultation Session has been sent to
tribal leaders via email and posted on
the Early Childhood Learning and
Knowledge Center Web site at https://
eclkc.ohs.acf.hhs.gov/hslc/
eclkc_main_calendar/tc-2013.
Dated: March 26, 2013.
Yvette Sanchez Fuentes,
Director, Office of Head Start.
[FR Doc. 2013–08029 Filed 4–4–13; 8:45 am]
BILLING CODE 4184–40–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0375]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Agreement for
Shipment of Devices for Sterilization
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
SUMMARY:
E:\FR\FM\05APN1.SGM
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Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Notices
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 either electronic or
written comments on the collection of
information by June 4, 2013.
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 FD&C 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 contract sterilizers. 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 4
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.
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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
mstockstill on DSK4VPTVN1PROD with NOTICES
Activity/21 CFR section
No. of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Agreement and labeling requirements, § 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.
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Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity/21 CFR section
No. of
recordkeepers
No. of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Record retention, § 801.150(a)(2) ........................................
90
20
1,800
0.5 *
900
* (30 minutes)
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 1, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2013–07916 Filed 4–4–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0370]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Export of Medical
Devices; Foreign Letters of Approval
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
reporting requirements for firms that
intend to export certain unapproved
medical devices.
DATES: Submit either electronic or
written comments on the collection of
information by June 4, 2013.
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.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:14 Apr 04, 2013
Jkt 229001
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
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
of automated collection techniques,
when appropriate, and other forms of
information technology.
Export of Medical Devices; Foreign
Letters of Approval—(OMB Control
Number 0910–0264)—Extension
Section 801(e)(2) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 381(e)(2)) provides for the
exportation of an unapproved device
under certain circumstances if the
exportation is not contrary to the public
health and safety and it has the approval
of the foreign country to which it is
intended for export. Requesters
communicate (either directly or through
a business associate in the foreign
country) with a representative of the
foreign government to which they seek
exportation, and written authorization
must be obtained from the appropriate
office within the foreign government
approving the importation of the
medical device. An alternative to
obtaining written authorization from the
foreign government is to accept a
notarized certification from a
responsible company official in the
United States that the product is not in
conflict with the foreign country’s laws.
This certification must include a
statement acknowledging that the
responsible company official making the
certification is subject to the provisions
of 18 U.S.C. 1001. This statutory
provision makes it a criminal offense to
knowingly and willingly make a false or
fraudulent statement, or make or use a
false document, in any manner within
the jurisdiction of a department or
agency of the United States. The
respondents to this collection of
information are companies that seek to
export medical devices. FDA’s estimate
of the reporting burden is based on the
experience of FDA’s medical device
program personnel.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\05APN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Notices]
[Pages 20658-20660]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07916]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0375]
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
[[Page 20659]]
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 either electronic or written comments on the collection
of information by June 4, 2013.
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 FD&C 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 contract sterilizers. 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 4 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.
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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section No. of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Agreement and labeling requirements, Sec. 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.
[[Page 20660]]
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of records Average burden
Activity/21 CFR section No. of per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Record retention, Sec. 801.150(a)(2)............................. 90 20 1,800 0.5 * 900
--------------------------------------------------------------------------------------------------------------------------------------------------------
* (30 minutes)
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 1, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07916 Filed 4-4-13; 8:45 am]
BILLING CODE 4160-01-P
