Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile, 3738-3739 [2010-1153]
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3738
Federal Register / Vol. 75, No. 14 / Friday, January 22, 2010 / Notices
System (OMB #0920–0612, exp. 1/31/
2010)—Revision—National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Cardiovascular disease (CVD), which
includes heart disease, myocardial
infarction, and stroke, is the leading
cause of death for women in the United
States, and is largely preventable. The
WISEWOMAN program (Well-Integrated
Screening and Evaluation for Women
Across the Nation), administered by the
Centers for Disease Control and
Prevention (CDC), was established to
examine ways of improving the delivery
of services for women who have limited
access to health care and elevated risk
factors for CVD. The program focuses on
reducing CVD risk factors and provides
screening services for select risk factors
such as elevated blood cholesterol,
hypertension and abnormal blood
glucose levels. The program also
provides lifestyle interventions and
medical referrals. The WISEWOMAN
program serves women who are
participating in the National Breast and
Cervical Cancer Early Detection Program
(NBCCEDP), also administered by CDC.
CDC requests OMB approval to
continue collecting information from
WISEWOMAN grantees for three years,
with changes. There will be a net
decrease in the total annualized burden
hours. Although the number of funded
grantees will increase from 15 to 21, the
burden per respondent will decrease
due to changes in the data collection
plan and schedule. The collection of
cost information will be discontinued
and the Progress Report will be
collected semi-annually instead of
quarterly.
Twice per year, each grantee will
electronically transmit a Minimum Data
Elements (MDE) dataset that contains
information about the women served
through the WISEWOMAN program,
including their demographics, health
status, CVD risk factors, referrals and
participation in lifestyle interventions.
In addition, each grantee will submit
two written progress reports per year.
The progress reports provide a narrative
summary of grantee activities, as well as
a discussion of each grantee’s progress
toward meeting stated programmatic
objectives. The information collected
from grantees is used to assess the
impact of the WISEWOMAN program.
The overall program evaluation is
designed to demonstrate how
WISEWOMAN can obtain more
complete health data on vulnerable
populations, promote public education
about disease incidence and risk-factors,
improve the availability of screening
and diagnostic services for under-served
women, ensure the quality of services
provided to under-served women, and
develop strategies for improved
interventions.
There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
1,680.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Form name
WISEWOMAN Grantees .................................
Screening and Assessment MDEs ................
Intervention MDEs ..........................................
Progress Report .............................................
Dated: January 15, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–1167 Filed 1–21–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0246]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Establishing and
Maintaining a List of U.S. Dairy
Product Manufacturers/Processors
With Interest in Exporting to Chile
erowe on DSK5CLS3C1PROD with NOTICES
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
VerDate Nov<24>2008
14:43 Jan 21, 2010
Jkt 220001
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 February
22, 2010.
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:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0509. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
21
21
21
Number of
responses per
respondent
2
2
2
Average
burden per
response
(in hours)
16
8
16
Establishing and Maintaining a List of
U.S. Dairy Product Manufacturers/
Processors With Interest in Exporting to
Chile (OMB Control Number 0910–
0509)—Extension
As a direct result of discussions that
have been adjunct to the U.S./Chile Free
Trade Agreement, Chile has recognized
FDA as the competent U.S. food safety
authority and has accepted the U.S.
regulatory system for dairy inspections.
Chile has concluded that it will not
require individual inspections of U.S.
firms by Chile as a prerequisite for
trade, but will accept firms identified by
FDA as eligible to export to Chile.
Therefore, in the Federal Register of
June 22, 2005 (70 FR 36190), FDA
announced the availability of a revised
guidance document entitled
‘‘Establishing and Maintaining a List of
U.S. Dairy Product Manufacturers/
Processors With Interest in Exporting to
Chile.’’ The guidance can be found at
https://www.cfsan.fda.gov/
guidance.html. The guidance document
explains that FDA has established a list
that is provided to the government of
Chile and posted on https://
E:\FR\FM\22JAN1.SGM
22JAN1
3739
Federal Register / Vol. 75, No. 14 / Friday, January 22, 2010 / Notices
www.cfsan.fda.gov/~comm/
expcllst.html, which identifies U.S.
dairy product manufacturers/processors
that have expressed interest to FDA in
exporting dairy products to Chile, are
subject to FDA jurisdiction, and are not
the subject of a pending judicial
enforcement action (i.e., an injunction
or seizure) or a pending warning letter.
The term ‘‘dairy products,’’ for purposes
of this list, is not intended to cover the
raw agricultural commodity raw milk.
Application for inclusion on the list is
voluntary. However, Chile has advised
that dairy products from firms not on
this list could be delayed or prevented
by Chilean authorities from entering
commerce in Chile. The guidance
explains what information firms should
submit to FDA in order to be considered
for inclusion on the list and what
criteria FDA intends to use to determine
eligibility for placement on the list. The
document also explains how FDA
intends to update the list and how FDA
intends to communicate any new
information to Chile. Finally, the
guidance notes that FDA considers the
information on this list, which is
provided voluntarily with the
understanding that it will be posted on
FDA’s Web site and communicated to,
and possibly further disseminated by,
Chile, to be information that is not
protected from disclosure under 5
U.S.C. 552(b)(4). Under the guidance,
FDA recommends that U.S. firms that
want to be placed on the list send the
following information to FDA: (1) Name
and address of the firm and the
manufacturing plant; (2) name,
telephone number, and e-mail address
(if available) of the contact person; (3)
a list of products presently shipped and
expected to be shipped in the next 3
years; (4) identities of agencies that
inspect the plant and the date of last
inspection; (5) plant number and copy
of last inspection notice; and (6) if other
than an FDA inspection, copy of last
inspection report. FDA requests that this
information be updated every 2 years.
In the Federal Register of June 4, 2009
(74 FR 26867), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
FDA received two letters in response,
each containing one or more comments.
The comments were outside the scope
of the comment request in the notice.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Activity
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
New written requests to be
placed on the list
15
1
15
1.5
23
Biannual update
88
1
88
1.0
88
Occasional updates
25
1
25
0.5
13
Total
erowe on DSK5CLS3C1PROD with NOTICES
1 There
124
are no capital or operating and maintenance costs associated with this collection of information.
The estimate of the number of firms
that will submit new written requests to
be placed on the list, biannual updates
and occasional updates is based on the
FDA’s experience maintaining the list
over the past 4 years. The estimate of
the number of hours that it will take a
firm to gather the information needed to
be placed on the list or update its
information is based on FDA’s
experience with firms submitting
similar requests. FDA believes that the
information to be submitted will be
readily available to the firms.
To date, over 175 producers have
sought to be included on the list. FDA
estimates that, each year, approximately
15 new firms will apply to be added to
the list. We estimate that a firm will
require 1.5 hours to read the guidance,
gather the information needed, and to
prepare a communication to FDA that
contains the information and requests
that the firm be placed on the list for a
total of 22.5 hours, rounded to 23.
Under the guidance, every 2 years each
producer on the list must provide
updated information in order to remain
on the list. FDA estimates that each year
approximately half of the firms on the
list, 88 firms (175 x 0.5 = 87.5, rounded
to 88), will resubmit the information to
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14:43 Jan 21, 2010
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remain on the list. We estimate that a
firm already on the list will require 1.0
hours to biannually update and
resubmit the information to FDA,
including time reviewing the
information and corresponding with
FDA, for a total of 88 hours. In addition,
FDA expects that, each year,
approximately 25 firms will need to
submit an occasional update and each
firm will require 0.5 hours to prepare a
communication to FDA reporting the
change, for a total of 12.5 hours,
rounded to 13.
Dated: January 15, 2010.
David Dorsey
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–1153 Filed 1–21–10; 8:45 am]
BILLING CODE 4160–01–S
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office on (301) 443–
1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
E:\FR\FM\22JAN1.SGM
22JAN1
]]>Agencies
[Federal Register Volume 75, Number 14 (Friday, January 22, 2010)]
[Notices]
[Pages 3738-3739]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-1153]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0246]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Establishing and
Maintaining a List of U.S. Dairy Product Manufacturers/Processors With
Interest in Exporting to Chile
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
February 22, 2010.
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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0509.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Establishing and Maintaining a List of U.S. Dairy Product
Manufacturers/Processors With Interest in Exporting to Chile (OMB
Control Number 0910-0509)--Extension
As a direct result of discussions that have been adjunct to the
U.S./Chile Free Trade Agreement, Chile has recognized FDA as the
competent U.S. food safety authority and has accepted the U.S.
regulatory system for dairy inspections. Chile has concluded that it
will not require individual inspections of U.S. firms by Chile as a
prerequisite for trade, but will accept firms identified by FDA as
eligible to export to Chile. Therefore, in the Federal Register of June
22, 2005 (70 FR 36190), FDA announced the availability of a revised
guidance document entitled ``Establishing and Maintaining a List of
U.S. Dairy Product Manufacturers/Processors With Interest in Exporting
to Chile.'' The guidance can be found at https://www.cfsan.fda.gov/guidance.html. The guidance document explains that FDA has established
a list that is provided to the government of Chile and posted on http:/
/
[[Page 3739]]
www.cfsan.fda.gov/~comm/expcllst.html, which identifies U.S. dairy
product manufacturers/processors that have expressed interest to FDA in
exporting dairy products to Chile, are subject to FDA jurisdiction, and
are not the subject of a pending judicial enforcement action (i.e., an
injunction or seizure) or a pending warning letter. The term ``dairy
products,'' for purposes of this list, is not intended to cover the raw
agricultural commodity raw milk. Application for inclusion on the list
is voluntary. However, Chile has advised that dairy products from firms
not on this list could be delayed or prevented by Chilean authorities
from entering commerce in Chile. The guidance explains what information
firms should submit to FDA in order to be considered for inclusion on
the list and what criteria FDA intends to use to determine eligibility
for placement on the list. The document also explains how FDA intends
to update the list and how FDA intends to communicate any new
information to Chile. Finally, the guidance notes that FDA considers
the information on this list, which is provided voluntarily with the
understanding that it will be posted on FDA's Web site and communicated
to, and possibly further disseminated by, Chile, to be information that
is not protected from disclosure under 5 U.S.C. 552(b)(4). Under the
guidance, FDA recommends that U.S. firms that want to be placed on the
list send the following information to FDA: (1) Name and address of the
firm and the manufacturing plant; (2) name, telephone number, and e-
mail address (if available) of the contact person; (3) a list of
products presently shipped and expected to be shipped in the next 3
years; (4) identities of agencies that inspect the plant and the date
of last inspection; (5) plant number and copy of last inspection
notice; and (6) if other than an FDA inspection, copy of last
inspection report. FDA requests that this information be updated every
2 years.
In the Federal Register of June 4, 2009 (74 FR 26867), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received two letters in response, each
containing one or more comments. The comments were outside the scope of
the comment request in the notice.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
Activity Respondents per Response Responses Hours per Response Total Hours
----------------------------------------------------------------------------------------------------------------
New written 15 1 15 1.5 23
requests to
be placed
on the list
----------------------------------------------------------------------------------------------------------------
Biannual 88 1 88 1.0 88
update
----------------------------------------------------------------------------------------------------------------
Occasional 25 1 25 0.5 13
updates
----------------------------------------------------------------------------------------------------------------
Total 124
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with this collection of information.
The estimate of the number of firms that will submit new written
requests to be placed on the list, biannual updates and occasional
updates is based on the FDA's experience maintaining the list over the
past 4 years. The estimate of the number of hours that it will take a
firm to gather the information needed to be placed on the list or
update its information is based on FDA's experience with firms
submitting similar requests. FDA believes that the information to be
submitted will be readily available to the firms.
To date, over 175 producers have sought to be included on the list.
FDA estimates that, each year, approximately 15 new firms will apply to
be added to the list. We estimate that a firm will require 1.5 hours to
read the guidance, gather the information needed, and to prepare a
communication to FDA that contains the information and requests that
the firm be placed on the list for a total of 22.5 hours, rounded to
23. Under the guidance, every 2 years each producer on the list must
provide updated information in order to remain on the list. FDA
estimates that each year approximately half of the firms on the list,
88 firms (175 x 0.5 = 87.5, rounded to 88), will resubmit the
information to remain on the list. We estimate that a firm already on
the list will require 1.0 hours to biannually update and resubmit the
information to FDA, including time reviewing the information and
corresponding with FDA, for a total of 88 hours. In addition, FDA
expects that, each year, approximately 25 firms will need to submit an
occasional update and each firm will require 0.5 hours to prepare a
communication to FDA reporting the change, for a total of 12.5 hours,
rounded to 13.
Dated: January 15, 2010.
David Dorsey
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-1153 Filed 1-21-10; 8:45 am]
BILLING CODE 4160-01-S
