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 of the information collection provisions of the Interstate Shellfish Dealer's Certificate program, and approval of the revised Form FDA 3038, titled, “Interstate Shellfish Dealer's Certificate.”
2. Purpose
and Use of the Information Collection
As
noted, each participating State and nation provides a certificate of
its certified shellfish processors to FDA on Form FDA 3038,
“Interstate Shellfish Dealer's Certificate.” The
information includes name, address, certification, information
regarding recent inspections, and the identification of the shellfish
control authority. FDA seeks OMB approval of a
minor
non-substantive change it would like to make to Form FDA
3038. In section 2(e) of the form, the respondent is asked to
provide the category symbol for the certification being made. FDA is
proposing to add two additional symbols as possible answers to this
data element/question, to maintain the form’s accuracy. The
data element/question remains unchanged.
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. 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 November 15, 2012 (77 FR 68129). FDA received one letter in response to the notice, containing multiple comments on the testing methods used by certified shellfish processors in the National Shellfish Sanitation Program. These comments were outside the scope of the four collection of information topics on which the notice requested comments.
12. Estimates of Annualized Burden Hours and Costs
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.”
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 and the number of certificates received in the past 3 years.
ESTIMATED ANNUAL REPORTING BURDEN
FDA Form No. |
No. of Respondents |
No. of Responses per Respondent |
Total Annual Responses |
Average Burden per Response |
Total Hours |
Form FDA 3038 |
40 |
57 |
2,280 |
0.10 |
228 |
12 b. Annualized Cost Burden Estimate
FDA estimates the annualized burden hour cost to respondents for this collection of information to be approximately $7,816.48. FDA estimates that this certification will be prepared by an employee making an average wage similar to that of a Federal government employee at the GS-5/Step-1 rate, in the Washington-Baltimore Locality Pay Area for the year 2013, which is $16.33 per hour. To account for overhead, this cost is increased by 100 percent, which is $32.66 per hour. Thus, the annual wage cost for completion and submission of these certifications is approximately $7,446.48 (228 hours x $32.66 per hour). Administrative cost, i.e. printing and mailing are estimated at $370.00. Therefore, total costs are $7,816.48 ($7,446.48 + $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 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 $18,272 in processing the data received in
these forms. Administrative expenses account for approximately $800
of this sum, and the remainder is personnel cost. FDA bases its
estimate on the salary of one full-time employee at the GS-8, Step 1
rate, in the Washington-Baltimore Locality Pay Area for the year 2013
who spends an estimated 780 hours on this program (780 hours x
$22.40/hour = $17,472). Thus, the total estimated cost to the
Federal government is approximately $18,272 ($17,472 + $800.00).
15. Explanation
for Program Changes or Adjustments
The
hour burden is unchanged. FDA proposes to make a minor
non-substantive change to Form FDA
3038. In section 2) e) of the form, the respondent is asked to
provide the category symbol for the certification being made. FDA is
proposing to add two additional symbols as possible answers to this
data element/question, to maintain the form’s accuracy. The
data element/question remains unchanged.
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 | Bean, Domini |
| File Modified | 2013-03-20 |
| File Created | 2013-03-20 |