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, 16511-16512 [2013-06017]

Download as PDF Federal Register / Vol. 78, No. 51 / Friday, March 15, 2013 / Notices these authorities, except the delegation memorandum from the Secretary to the Assistant Secretary for Children and Families, dated February 9, 2004. This delegation is effective immediately. Dated: February 27, 2013. George H. Sheldon, Acting Assistant Secretary for Children and Families. [FR Doc. 2013–06057 Filed 3–14–13; 8:45 am] BILLING CODE 4154–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Administration for Children and Families Delegation of Authority Administration for Community Living and Administration for Children and Families, HHS. ACTION: Notice. srobinson on DSK4SPTVN1PROD with NOTICES AGENCY: SUMMARY: The delegation of authorities for Title II, Subpart D, Parts 2 and 5 of the Help America Vote Act are being delegated from the Assistant Secretary, Administration for Children and Families, to the Administrator, Administration for Community Living (ACL). This action is necessary to complete the transition of the Administration on Intellectual and Developmental Disabilities to the Administration for Community Living from the Administration for Children and Families, consistent with the Federal Register notice of reorganization as last amended, 77 FR 23250–23260, April 18, 2012. FOR FURTHER INFORMATION CONTACT: Jason Bennett, Acting Executive Secretary, Administration for Community Living at 202–357–3408. Under the authority vested in the Assistant Secretary for Children and Families by memorandum from the Secretary, ‘‘Delegations of Authority for the Programs Authorized Under Title II, Subtitle D, Parts 2 and 5 of the Help America Vote Act of 2002, Public Law 107–252, 116 Stat 1666, 1698–1699, 1702–1703 (2002),’’ dated February 9, 2004, notice is hereby given that the Assistant Secretary for Children and Families has delegated to the Administrator for the Administration for Community Living the authorities under Title II, Subpart D, Parts 2 and 5 of the Help America Vote Act of 2002, 42 U.S.C. 15421–15425, 15461–15462, and as amended hereafter, as they pertain to the functions assigned to the functions VerDate Mar<14>2013 17:37 Mar 14, 2013 Jkt 229001 of the Administrator for the Administration for Community Living. These authorities may be redelegated. These authorities shall be exercised under the Department’s policy on regulations and the existing delegation of authority to approve and issue regulations. This delegation shall be exercised under financial and administrative requirements applicable to all Administration for Community Living authorities. I hereby affirm and ratify any actions taken by the Administrator for the Administration for Community Living, or his or her subordinates, which involved the exercise of the authorities delegated herein prior to the effective date of this delegation. This delegation will concurrently supersede all existing delegations of these authorities, except the delegation memorandum from the Secretary to the Assistant Secretary for Children and Families, dated February 9, 2004. This delegation is effective immediately. Dated: February 27, 2013. George H. Sheldon, Acting Assistant Secretary for Children and Families. [FR Doc. 2013–06056 Filed 3–14–13; 8:45 am] BILLING CODE 4154–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–1106] 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 April 15, 2013. To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of ADDRESSES: PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 16511 Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed 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: Domini Bean, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 5733, domini.bean@fda.hhs.gov. 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.fda.gov/Food/Guidance ComplianceRegulatoryInformation/ GuidanceDocuments/ImportsExports/ ucm078936.htm. The guidance document explains that FDA has established a list that is provided to the government of Chile and posted on https://www.fda.gov/Food/International Activities/Exports/ucm120245.htm, 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 E:\FR\FM\15MRN1.SGM 15MRN1 16512 Federal Register / Vol. 78, No. 51 / Friday, March 15, 2013 / Notices 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: Name and address of the firm and the manufacturing plant; name, telephone number, and email 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 November 15, 2012 (77 FR 68128), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Number of responses per respondent Average burden per response Total annual responses Total hours New written requests to be placed on the list ..................... Biannual update ................................................................... Occasional updates ............................................................. 25 88 25 1 1 1 25 88 25 1.5 1.0 0.5 38 88 13 Total .............................................................................. ........................ ........................ ........................ ........................ 139 srobinson on DSK4SPTVN1PROD with NOTICES 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 7 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. On average, over the last 3 years, the list contained approximately 176 firms. FDA estimates that, each year, approximately 25 new firms will apply to be added to the list. In any given year, some firms choose not to resubmit their information. These firms are removed from the list quarterly. This occurrence results in the number of firms to remain at approximately 176. 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 37.5 hours, rounded to 38. 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 (176 × 0.5 = 88), will resubmit the information to remain on the list. We estimate that a firm already VerDate Mar<14>2013 17:37 Mar 14, 2013 Jkt 229001 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: March 12, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–06017 Filed 3–14–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–1108] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Interstate Shellfish Dealer’s Certificate 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 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 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 April 15, 2013. 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 emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0021. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400, Rockville, MD 20850, 301–796– 5733, domini.bean@fda.hhs.gov. 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. Interstate Shellfish Dealer’s Certificate (OMB Control Number 0910–0021)— Extension Under section 243 of the Public Health Service Act (42 U.S.C. 243), FDA is required to cooperate with and aid State and local authorities in the enforcement of their health regulations E:\FR\FM\15MRN1.SGM 15MRN1

Agencies

[Federal Register Volume 78, Number 51 (Friday, March 15, 2013)]
[Notices]
[Pages 16511-16512]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06017]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1106]

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 April
15, 2013.

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 emailed 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: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-5733, domini.bean@fda.hhs.gov.

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.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ImportsExports/ucm078936.htm. The guidance document explains that FDA
has established a list that is provided to the government of Chile and
posted on https://www.fda.gov/Food/InternationalActivities/Exports/ucm120245.htm, 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

[[Page 16512]]

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: Name and address of the
firm and the manufacturing plant; name, telephone number, and email
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 November 15, 2012 (77 FR 68128), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
New written requests to be 25 1 25 1.5 38
placed on the list.............
Biannual update................. 88 1 88 1.0 88
Occasional updates.............. 25 1 25 0.5 13
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 139
----------------------------------------------------------------------------------------------------------------
\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 7 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.
On average, over the last 3 years, the list contained approximately
176 firms. FDA estimates that, each year, approximately 25 new firms
will apply to be added to the list. In any given year, some firms
choose not to resubmit their information. These firms are removed from
the list quarterly. This occurrence results in the number of firms to
remain at approximately 176. 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 37.5 hours,
rounded to 38. 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 (176 x 0.5 = 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: March 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06017 Filed 3-14-13; 8:45 am]
BILLING CODE 4160-01-P

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