Agency Information Collection Activities; Proposed Collection; Comment Request; Exports: Notification and Recordkeeping Requirements, 75677-75678 [2010-30433]
Download as PDF
<![CDATA[
Federal Register / Vol. 75, No. 233 / Monday, December 6, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–New; 30-day
notice]
Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Secretary, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Office of the Secretary (OS), Department
of Health and Human Services, is
publishing the following summary of a
proposed collection for public
comment. Interested persons are invited
to send comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, e-mail your request,
AGENCY:
including your address, phone number,
OMB number, and OS document
identifier, to
Sherette.funncoleman@hhs.gov, or call
the Reports Clearance Office on (202)
690–5683. Send written comments and
recommendations for the proposed
information collections within 30 days
of this notice directly to the OS OMB
Desk Officer; faxed to OMB at 202–395–
5806.
Proposed Project: Prevention and
Wellness-Leveraging National
Organizations- OMB No. 0990–NewOffice of Public Health and Science.
Abstract: The Office of Public Health
and Science is requesting an approval
by OMB on a new collection. The
American Recovery and Reinvestment
Act (ARRA) Prevention and WellnessLeveraging National Organizations is a
cooperative agreement program
authorized under 42 U.S.C. 300k–1, 300,
section 1701 of the Public Health
Service Act, as amended. The funding
opportunity focuses on two categories of
activities:
• Category A: Obesity prevention
through improved nutrition and
increased physical activity
• Category B: Tobacco prevention and
control
The National Organizations who
receive funding will be supporting
Communities Putting Prevention to
Work (CPPW)-funded communities by
providing expertise and technical
75677
assistance to help implement select
MAPPS (Media, Access, Point of
Purchase/Promotion, Pricing, and Social
Support and Services) strategies through
national organizations’ systems and
networks. The National Organizations
will work to sustain community
prevention efforts beyond Recovery Act
CPPW funding and support the National
Prevention Media Initiative through cobranding and augmenting HHSdeveloped media campaigns in
communities.
The outcome measures that will be
collected from funded National
Organizations include approval/
enactment of MAPPS-related policy,
systems, and environmental change in
physical activity, nutrition, and tobacco
in funded communities. Since a critical
component of the National
Organizations is to support and assist
CPPW-funded communities with their
expert resources, the National
Organizations and the CPPW-funded
communities will share ownership of
the same outcome measures. Because
the National Organizations and their
local affiliates have a distinct
supporting role in these communitywide efforts, the output measures track
the kinds of added-value to be derived
from involvement of the National
Organizations and its local affiliates in
the community-wide efforts which
should help drive the outcome measure.
ESTIMATED ANNUALIZED BURDEN TABLE
Forms
Type of respondent
Number of
respondents
Number of
responses per
respondent
Average burden
(in hours) per
response
Total burden
hours
National Organizations Measures
Instrument.
Cooperative Agreement recipients—National Organizations.
10
4
2
80
Seleda Perryman,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 2010–30435 Filed 12–3–10; 8:45 am]
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
jdjones on DSK8KYBLC1PROD with NOTICES
[Docket No. FDA–2010–N–0595]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Exports:
Notification and Recordkeeping
Requirements
AGENCY:
Food and Drug Administration,
HHS.
VerDate Mar<15>2010
15:27 Dec 03, 2010
Jkt 223001
ACTION:
Notice.
cosmetics that may not be marketed or
sold in the United States.
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 notification and recordkeeping
requirements for persons exporting
human drugs, biological products,
devices, animal drugs, food, and
SUMMARY:
PO 00000
Frm 00016
Fmt 4703
Sfmt 4703
Submit either electronic or
written comments on the collection of
information by February 4, 2011.
DATES:
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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
E:\FR\FM\06DEN1.SGM
06DEN1
75678
Federal Register / Vol. 75, No. 233 / Monday, December 6, 2010 / Notices
Administration, 1350 Piccard Dr., PI50–
410B, Rockville, MD 20850, 301–796–
3794, E-mail:
Jonnalynn.Capezzuto@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.
Exports: Notification and
Recordkeeping Requirements—21 CFR
Part 1 (OMB Control Number 0910–
0482)—Extension
The respondents to this information
collection are exporters who have
notified FDA of their intent to export
unapproved products that may not be
sold or marketed in the United States as
allowed under section 801(e) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 381). In
general, the notification identifies the
product being exported (e.g., name,
description, and in some cases, country
of destination) and specifies where the
notification should be sent. These
notifications are sent only for an initial
export; subsequent exports of the same
product to the same destination (or, in
the case of certain countries identified
in section 802(b) of the FD&C Act (21
U.S.C. 382)) would not result in a
notification to FDA.
The recordkeepers for this
information collection export human
drugs, biologics, devices, animal drugs,
foods, and cosmetics that may not be
sold in the United States and maintain
records demonstrating their compliance
with the requirements in section
801(e)(1) of the FD&C Act.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section
Number of
respondents
Annual
frequency
per response
Total
annual
responses
Hours per
response
Total hours
1.101 (d) to (e) .....................................................................
400
3
1,200
15
18,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR Section
Number of
recordkeepers
Annual
frequency per
recordkeeping
Total annual
records
Hours per
record
Total
hours
1.101 (b) to (c) ...........................................................
320
3
960
22
21,120
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–30433 Filed 12–3–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
jdjones on DSK8KYBLC1PROD with NOTICES
[Docket Nos. FDA–2010–E–0032 and FDA–
2010–E–0036]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; STELARA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Mar<15>2010
15:27 Dec 03, 2010
Jkt 223001
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
STELARA and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human biological
product.
SUMMARY:
Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions along with three copies and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
ADDRESSES:
PO 00000
Frm 00017
Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
and the Generic Animal Drug and Patent
Term Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
SUPPLEMENTARY INFORMATION:
E:\FR\FM\06DEN1.SGM
06DEN1
]]>Agencies
[Federal Register Volume 75, Number 233 (Monday, December 6, 2010)]
[Notices]
[Pages 75677-75678]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30433]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0595]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Exports: Notification and Recordkeeping Requirements
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 notification and
recordkeeping requirements for persons exporting human drugs,
biological products, devices, animal drugs, food, and cosmetics that
may not be marketed or sold in the United States.
DATES: Submit either electronic or written comments on the collection
of information by February 4, 2011.
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: Jonna Capezzuto, Office of Information
Management, Food and Drug
[[Page 75678]]
Administration, 1350 Piccard Dr., PI50-410B, Rockville, MD 20850, 301-
796-3794, E-mail: Jonnalynn.Capezzuto@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.
Exports: Notification and Recordkeeping Requirements--21 CFR Part 1
(OMB Control Number 0910-0482)--Extension
The respondents to this information collection are exporters who
have notified FDA of their intent to export unapproved products that
may not be sold or marketed in the United States as allowed under
section 801(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 381). In general, the notification identifies the
product being exported (e.g., name, description, and in some cases,
country of destination) and specifies where the notification should be
sent. These notifications are sent only for an initial export;
subsequent exports of the same product to the same destination (or, in
the case of certain countries identified in section 802(b) of the FD&C
Act (21 U.S.C. 382)) would not result in a notification to FDA.
The recordkeepers for this information collection export human
drugs, biologics, devices, animal drugs, foods, and cosmetics that may
not be sold in the United States and maintain records demonstrating
their compliance with the requirements in section 801(e)(1) of the FD&C
Act.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section Number of frequency per Total annual Hours per Total hours
respondents response responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.101 (d) to (e)................................................... 400 3 1,200 15 18,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section Number of frequency per Total annual Hours per record Total hours
recordkeepers recordkeeping records
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.101 (b) to (c).............................................. 320 3 960 22 21,120
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30433 Filed 12-3-10; 8:45 am]
BILLING CODE 4160-01-P
