SUPPORTING STATEMENT
1. Circumstances
Making the Collection of Information Necessary
As
a direct result of discussions that have been adjunct to the United
States-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
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ImportsExports/ucm078936.htm.
The guidance document is published under the authority of Section 701(h) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 371(h)), which authorizes the Secretary to develop guidance documents with public participation presenting the views of the Secretary on matters under the jurisdiction of the FDA.
The guidance document explains that FDA has established a list that is provided to the government of Chile and posted on FDA's website, 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 website 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. FDA shares this information with Chile pursuant to 21 CFR 20.89, under our authority to share with foreign government officials, among other types of information, investigatory records compiled for law enforcement purposes as well as any information voluntarily submitted to the FDA.
FDA requests the extension of OMB approval of the information collection provisions of the guidance document entitled, “Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors with Interest in Exporting to Chile.”
2. Purpose
and Use of the Information Collection
FDA
uses the information submitted by firms to determine their
eligibility for placement on the list, which is published on the
agency’s website. The
purpose of the list is to assist
the government of Chile in its determination of which U.S. dairy
product manufacturers are eligible to export to Chile.
Description of Respondents: Respondents to this information collection include U.S. dairy product manufacturers/processors. Respondents are from the private sector (for profit businesses).
3. Use
of Improved Information Technology and Burden Reduction
FDA
continually seeks ways to reduce reporting burden. Presently, U.S.
firms may submit information by letter sent via the U.S. Postal
Service or overnight delivery, facsimile, or e-mail.
FDA estimates that fifty percent (50%) of the respondents will use electronic means to submit their information.
4. Efforts
to Identify Duplication and Use of Similar Information
The
information collection is a unique collection for the purpose of
assisting the government of Chile in its determination of which U.S.
dairy product manufacturers are eligible to export to Chile. This
was one of several agricultural trade issues whose resolution was
tied to the United States – Chile Free Trade Agreement. Some,
but not all, of the necessary information is collected by FDA or the
U.S. Department of Agriculture (USDA) for other purposes, for
example, the “The
Interstate Milk Shippers (IMS) List for Grade ‘A’ Dairy
Plants” and “The List of Dairy Plants Surveyed and
Approved for USDA Grading Service.” However,
it is not practical to use the information on these lists for the
purpose of assisting the government of Chile. These lists are
product specific and may not include the products that the firms
intend to export to Chile. The USDA list is a voluntary listing with
a fee for those firms who wish to have their products graded. The
IMS list is only for Grade A milk products and does not include
non-Grade A products (e.g., cheese or ice cream). Approximately 60
firms were not listed on the IMS list and the USDA list.
In
addition, documentation requirements require a unique collection of
information. FDA believes that it is necessary for the agency to
create a complete and unique file corresponding to each initial
request for placement on the list. The documentation contained in
this file would include all relevant information necessary to
demonstrate satisfaction of the minimum conditions for listing of a
firm, including a copy of the most current inspection report, whether
that inspection was conducted by FDA or by another regulatory entity,
i.e., USDA or a State regulatory agency. A firm’s presence on
any other list would not be sufficient to document satisfaction of
the listing criteria.
5. Impact
on Small Businesses or Other Small Entities
FDA
estimates that approximately ten percent (10%) of the respondents are
small businesses.
However, because
the collection gathers the minimum information that a business is
required to submit to qualify to be placed on the list, there is no
way to reduce the burden on small businesses. FDA
aids small businesses through the agency’s Regional Small
Business Representatives and through the scientific and
administrative staffs within the agency.
6. Consequences
of Collecting the Information Less Frequently
The
data in new requests to be placed on the list are submitted only
once. A business is requested to submit occasional updates if the
previously submitted information changes. In addition, FDA requests
that firms update their information biennially. If the information
collection is not conducted, 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.
7. Special
Circumstances
Relating to the
Guidelines of 5 CFR 1320.5
There
are no special circumstances associated with this collection of
information.
8. Comments
in Response to the Federal Register Notice and Efforts to Consult
Outside the Agency
In
accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for
public comment in the Federal Register of June 4, 2009 (74 FR 26867).
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.
12. Estimates
of Annualized Burden Hours and Costs
12
a. Annualized Hour Burden Estimate
FDA estimates the burden of this collection of information as follows:
Estimated Annual Reporting Burden
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 30/60 |
23 |
Biennial update |
88 |
1 |
88 |
1.0 |
88 |
Occasional updates |
25 |
1 |
25 |
30/60 |
13 |
Total |
|
|
|
|
124 |
The total estimated hour burden associated with this collection is 124 hours annually. The estimate of the number of firms that will submit new written requests to be placed on the list, biennial updates and occasional updates is based on 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 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, to 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 firms x 0.5 = 87.5, rounded to 88 firms), will resubmit the information to remain on the list. We estimate that a firm already on the list will require 1.0 hours to biennially 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.
12 b. Annualized Cost Burden Estimate
FDA estimates the annualized burden hour cost to respondents for this collection of information to be approximately $9,265.28. FDA estimates that the new written requests, biennial updates and occasional updates will be prepared by an employee making an average wage similar that of a Federal government employee at the GS-12/Step-3 rate for the Washington-Baltimore locality pay area for the year 2009, which is $37.36 per hour. To account for overhead, this cost is increased by 100 percent, which is $74.72 per hour. Thus, the annual wage cost for completion and submission of these requests and updates is approximately $9,265.28 (124 hours x $74.72 per hour).
13. Estimates of Other
Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There
are no capital, start-up, operating, or maintenance costs associated
with this information collection.
14. Annualized
Cost to the
Federal Government
The
annualized cost to the Federal government for the review and
evaluation of requests and updates submitted by U.S. dairy product
manufacturers is approximately $2,895.40. FDA bases its estimate on
the salary of one (1) full-time employee (FTE) at GS-12, Step 3, in
the Washington-Baltimore Locality Pay Area for the year 2009, who
spends an estimated 77.5 hours (77.5 hours x $37.36/hour
= $2,895.40).
15. Explanation
for Program Changes or Adjustments
The
burden has increased from 91 hours to 124 hours. This adjustment is
a result of an increase in the estimated numbers of respondents
filing biennial updates, from 55 to 88 respondents.
16. Plans for Tabulation and Publication and Project Time Schedule
FDA publishes the List of U.S.
Dairy Product Manufacturers/Processors with Interest in Exporting to
Chile on its website and shares the information with Chile, which may
post some or all of the information on its website.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
There
are no reasons why display of the expiration date for OMB approval of
the information collection would be inappropriate.
18. Exceptions
to Certification for Paperwork Reduction Act Submissions
There
are no exceptions to the certification.
| File Type | application/msword |
| File Title | Supporting Statement for |
| Author | Joanna Capezzuto |
| Last Modified By | DPresley |
| File Modified | 2010-01-26 |
| File Created | 2010-01-26 |