SUPPORTING STATEMENT
1. Circumstances
Making the Collection of Information Necessary
Under
42 U.S.C. 243, FDA is required to cooperate with and aid State and
local authorities in the enforcement of their health regulations and
is authorized to assist States in the prevention and suppression of
communicable diseases. Under this authority, FDA participates with
State regulatory agencies, some foreign nations, and the molluscan
shellfish industry in the National Shellfish Sanitation Program
(NSSP).
Molluscan shellfish consumed fresh (raw) and fresh frozen poses unique public health concerns. The safety of molluscan shellfish directly reflects the cleanliness of the waters where they are grown. Molluscan shellfish are nonmotile, filter feeding organisms that pump large quantities of water through their bodies during their normal feeding process. The relationship between shellfish harvesting waters that are contaminated with sewage and other forms of pollution and food safety concerns has been demonstrated often. Additionally, molluscan shellfish must be held, packed, and shipped under sanitary conditions to prevent contamination subsequent to harvest and prior to delivery to the consumer.
The NSSP is a voluntary, cooperative program to promote the safety of molluscan shellfish by providing for the classification and patrol of shellfish growing waters and for the inspection and certification of shellfish processors. Each participating State and foreign nation monitors its molluscan shellfish processors and issues certificates for those that meet the State or foreign shellfish control authority's criteria. Each participating State and nation provides a certificate of its certified shellfish processors to FDA on Form FDA 3038, “Interstate Shellfish Dealer's Certificate.” FDA uses this information to publish the “Interstate Certified Shellfish Shippers List,” a monthly comprehensive listing of all molluscan shellfish processors certified under the cooperative program.
If FDA did not collect the information necessary to compile this list, participating States would not be able to identify and keep out shellfish processed by uncertified processors in other States and foreign nations. Consequently, the NSSP would not be able to control the distribution of uncertified and possibly unsafe shellfish in interstate commerce, and its effectiveness would be nullified.
FDA requests the extension of OMB approval for Form FDA 3038, Interstate Shellfish Dealer's Certificate.
2. Purpose
and Use of the Information Collection
FDA
uses this information to publish the “Interstate Certified
Shellfish Shippers List,” a monthly comprehensive listing of
all molluscan shellfish processors certified under the cooperative
program. State and local food control officials and the food
industry use the list to determine certified sources of shellfish.
Shellfish offered for sale that originate from non-listed dealers
will be removed by State and local food control officials. This
procedure assists FDA and the states to assure that shellfish are
produced, packed and shipped under proper sanitary controls to
protect the health of consumers of molluscan shellfish.
Description
of Respondents: Respondents to this information collection are
participating State and local regulatory agencies and foreign
nations. Respondents are “State, Local or Tribal
Governments.”
3. Use
of Improved Information Technology and Burden Reduction
The
Interstate Shellfish Dealers Certificate Form FDA 3038 may be
submitted on paper or submitted electronically by state or
international officials. These officials securely log into a
shellfish shippers account to fill out the Form FDA 3038
electronically. The information obtained from the form has been
entirely automated. The forms transmitted by the states, after
approval by an FDA official, are entered into a FDA computer database
program that allows the addition, deletion, down loading and
generating of the Interstate Certified Shellfish Shippers
List, published monthly in PDF format, and may
be updated daily when new data is available.
FDA
estimates that ninety percent (90%) of the respondents will use
electronic means to submit the Form FDA 3038.
4. Efforts
to Identify Duplication and Use of Similar Information
There
is no other information available that can be used for these
purposes. The FDA is
the only Federal agency that collects this information. There are no
similar data that can be used or modified for this use. This
information is only provided to FDA when a
State or foreign nation issues certificates for those processors that
meet the State or foreign shellfish control authority's criteria.
Therefore, the information being submitted to the agency will be
original for each submission.
5. Impact
on Small Businesses or Other Small Entities
Respondents
are State and local regulatory agencies and foreign nations, not
businesses. No small businesses will be involved in this information
collection.
6. Consequences
of Collecting the Information Less Frequently
Respondents
submit the required information on a yearly basis, as determined by
applicable State or foreign law. Each State has a different
expiration date for its certifications; therefore, there is a need
for year-round collection of data. However, most States certify for
a one year period or the applicable shellfish season within that
State's jurisdiction.
If
the information was not collected the consequences to the program
would be to nullify its effectiveness to control shellfish in
interstate commerce. Without the collection and periodic
dissemination of this list of certified shellfish dealers, the
existing public health controls pertaining to molluscan shellfish in
interstate commerce would be less effective. States that are in the
program are not willing to receive shellfish from noncertified
shippers.
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 2, 2009 (74 FR 26407).
FDA received one letter in response, which contained multiple
comments. One comment was generally supportive of the Interstate
Certified Shellfish Shippers List program and recommended maintaining
the program as it currently exists. Another comment noted that it
requires little effort to input information into the form and that
the Interstate Certified Shellfish Shippers List is critically
important to the National Shellfish Sanitation Program. FDA agrees
with the comments.
12. Estimates
of Annualized Burden Hours and Costs
12
a. Annualized Hour Burden Estimate
FDA estimates the burden of this collection of information to be 228 hours.
There are a total of 40 respondents. In the past year the program received approximately 2,280 responses, or an average of 57 responses per respondent. The respondents complete a three part Form FDA 3038, Interstate Shellfish Dealer's Certificate, using the information they have collected previously during state and international inspections. The original copy of this form is sent to FDA, the other parts are retained for their files. The information is readily available from state and international records which must be kept to satisfy their own laws and regulations. FDA estimates that it takes a respondent an average of 6 minutes, or 0.1 hours, to complete each form. Therefore, 2,280 responses x 0.10 hours = 228 hours total response time. FDA bases its estimate on its experience with similar certification programs.
ESTIMATED ANNUAL REPORTING BURDEN
FDA Form No. |
No. of Respondents |
Annual Frequency per Response |
Total Annual Responses |
Hours per Response |
Total Hours |
Form FDA 3038 |
40 |
57 |
2,280 |
6/60 |
228 |
12 b. Annualized Cost Burden Estimate
FDA estimates the annualized burden hour cost to respondents for this collection of information to be approximately $7,091.44. FDA estimates that this certification will be prepared by an employee making an average wage similar that of a Federal government employee at the GS-5/Step-1 rate for the year 2009, which is $14.74 per hour. To account for overhead, this cost is increased by 100 percent, which is $29.48 per hour. Thus, the annual wage cost for completion and submission of these certifications is approximately $6,721.44 (228 hours x $29.48 per hour). Administrative cost, i.e. printing and mailing are estimated at $370.00. Therefore, total costs are $7,091.44 ($6,721.44 + $370.00).
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
FDA
receives approximately 2,280 responses from 40 respondents annually
which include the States and some international countries. FDA
estimates that it expends $17,858.60 in processing the data received
in these forms. Administrative expenses account for approximately
$800 of this sum, and the remainder is a personnel cost. FDA bases
its estimate on the salary of one full-time employee at GS-8, Step 1,
in the Washington-Baltimore Locality Pay Area for the year 2009 who
spends an estimated 780 hours on this program (780 hours x
$21.87/hour = $17,058.60). Thus, the total estimated cost to the
Federal government is approximately $17,858.60 ($17,058.60 +
$800.00).
15. Explanation
for Program Changes or Adjustments
The
burden has decreased from 242 hours to 228 hours. This adjustment is
a result of an increase in the estimated number of respondents and a
reduction in the frequency per response from 62 to 57.
16. Plans for Tabulation and Publication and Project Time Schedule
FDA
publishes the “Interstate Certified Shellfish Shippers List”
on the Internet on a monthly basis.
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 | 2010-01-27 |
| File Created | 2010-01-27 |