Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishing and Maintaining a List of United States Dairy Product Manufacturers/Processors With Interest in Exporting to Chile, 70972-70973 [E6-20704]

Download as PDF 70972 Federal Register / Vol. 71, No. 235 / Thursday, December 7, 2006 / Notices Dated: November 28, 2006. John R. Dyer, Chief Operating Officer, Centers for Medicare & Medicaid Services. [FR Doc. E6–20743 Filed 12–6–06; 8:45 am] BILLING CODE 4120–03–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity: Comment Request Proposed Projects Title: Compassion Capital Fund Evaluation—Indicators of Organizational Capacity Among Targeted Capacity Building Program Grantees. OMB No.: New Collection. Description: This proposed information collection activity is for a study that is one component of the evaluation of the Compassion Capital Fund (CCF) program. The information collection will be through mailed surveys to be completed by selected faith-based and community organizations that received Targeted Capacity Building grants under the CCF program. The overall evaluation includes multiple components that will examine indicators, outcomes and effectiveness of the CCF in meeting its objective of improving the capacity of faith-based and community organizations. This component of the evaluation will involve approximately 250 faith-based and community organizations. Information will be sought from these organizations to assess change and improvement in various areas of organizational capacity resulting from receipt of a Targeted Capacity Building grant. Respondents: The respondents will be selected faith-based and community organizations that received a Targeted Capacity Building grant in a prior year. The surveys will be self-administered. Annual Burden Estimates: Number of respondents Number of responses per respondent Average burden hours per response Total burden hours Indicators of Organizational Capacity Survey ................................................. sroberts on PROD1PC70 with NOTICES Instrument 250 1 .33 82.5 Estimated Total Annual Burden Hours: 82.5 In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade SW., Washington, DC 20447. Attn: ACF Reports Clearance Officer. E-mail address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents. Consideration will be given to comments and suggestions submitted within 60 days of this publication. VerDate Aug<31>2005 17:29 Dec 06, 2006 Jkt 211001 Dated: December 1, 2006. Robert Sargis, Reports Clearance Office. [FR Doc. 06–9581 Filed 12–6–06; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N–0274] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishing and Maintaining a List of United States 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 January 8, 2007. 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, PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 OMB, Attn: FDA Desk Officer, FAX: 202–395–6974. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4659. 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 United States 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 E:\FR\FM\07DEN1.SGM 07DEN1 70973 Federal Register / Vol. 71, No. 235 / Thursday, December 7, 2006 / Notices that is provided to the government of Chile and posted on FDA’s Internet site, 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 revised 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 revised 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 Internet 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 this guidance, FDA recommends that U.S. firms that want to be placed on the list send the following information to FDA: Name and address of the firm and the manufacturing plant; name, telephone number, and e-mail address (if available) of the contact person; a list of products presently shipped and expected to be shipped in the next 3 years; identities of agencies that inspect the plant and the date of last inspection; plant number and copy of last inspection notice; and, 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 July 31, 2006 (71 FR 43202), FDA published a 60–day notice requesting public comment on the information collection provisions. No comments were received. TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 Activity No. of Respondents New Written Requests To Be Placed On The List Biannual Update Occasional Updates Total sroberts on PROD1PC70 with NOTICES 1There Annual Frequency per Response 15 55 25 Total Annual Responses 1 1 1 Hours per Response 15 55 25 Total Hours 1.5 1.0 0.5 22.5 55.0 12.5 90 are no capital costs 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 3 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 110 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. FDA estimates 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. Under the revised 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, 55 firms, will resubmit the information to remain on the list. FDA estimates 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 VerDate Aug<31>2005 17:29 Dec 06, 2006 Jkt 211001 information and corresponding with FDA. 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. Dated: November 30, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–20704 Filed 12–6–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N–0426] Withdrawal of Federal Register Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice; withdrawal. SUMMARY: The Food and Drug Administration (FDA) is announcing the withdrawal of a 60-day notice that published in the Federal Register of October 31, 2006 (71 FR 63765). The document published in error. DATES: December 7, 2006. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 1472. SUPPLEMENTARY INFORMATION: FDA is withdrawing a 60-day notice entitled ‘‘Medical Device User Fee and Modernization Act Small Business Qualification Certification (Form FDA 3602),’’ which published in the Federal Register of October 31, 2006 (71 FR 63765), because it is a duplicate of an earlier 60-day notice. The earlier 60-day notice published in the Federal Register of August 29, 2006 (71 FR 51196). The October 31 notice was published in error. Dated: November 30, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–20705 Filed 12–6–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2) notice E:\FR\FM\07DEN1.SGM 07DEN1

Agencies

[Federal Register Volume 71, Number 235 (Thursday, December 7, 2006)]
[Notices]
[Pages 70972-70973]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-20704]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0274]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Establishing and
Maintaining a List of United States 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 January
8, 2007.

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: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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 United States 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

[[Page 70973]]

that is provided to the government of Chile and posted on FDA's
Internet site, 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 revised 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 revised 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 Internet 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 this guidance, FDA recommends that U.S. firms that
want to be placed on the list send the following information to FDA:
Name and address of the firm and the manufacturing plant; name,
telephone number, and e-mail address (if available) of the contact
person; a list of products presently shipped and expected to be shipped
in the next 3 years; identities of agencies that inspect the plant and
the date of last inspection; plant number and copy of last inspection
notice; and, 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 July 31, 2006 (71 FR 43202), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.

Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Activity Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
New Written 15 1 15 1.5 22.5
Requests To
Be Placed On
The List
Biannual 55 1 55 1.0 55.0
Update
Occasional 25 1 25 0.5 12.5
Updates
Total ................. ................. .................... ................. 90
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs 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 3 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 110 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. FDA estimates 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. Under the revised 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, 55 firms, will resubmit the information
to remain on the list. FDA estimates 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. 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.

Dated: November 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-20704 Filed 12-6-06; 8:45 am]
BILLING CODE 4160-01-S

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