SUPPORTING STATEMENT
Terms of Clearance: None.
1. Circumstances
Making the Collection of Information Necessary
Section
401 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 341) directs FDA to issue regulations establishing
definitions and standards of identity for food “[w]henever * *
* such action will promote honesty and fair dealing in the interest
of consumers * * *.” Under section 403(g) of the FD&C Act
(21 U.S.C. 343(g)), a food that is subject to a definition and
standard of identity prescribed by regulation is misbranded if it
does not conform to such definition and standard of identity.
Section 130.17 (§ 130.17) provides for the issuance by FDA of
temporary marketing permits that enable the food industry to test
consumer acceptance and measure the technological and commercial
feasibility in interstate commerce of experimental packs of food that
deviate from applicable definitions and standards of identity.
Section 130.17(c) enables the Agency to monitor the manufacture,
labeling, and distribution of experimental packs of food that deviate
from applicable definitions and standards of identity. The
information so obtained can be used in support of a petition to
establish or amend the applicable definition or standard of identity
to provide for the variations. Section 130.17(i) specifies the
information that a firm must submit to FDA to obtain an extension of
a temporary marketing permit.
We request OMB approval for the following information collection requirements contained in §130.17:
21 CFR 130.17(c) Reporting
Provides format and information for a request for a temporary marketing permit.
21 CFR 130.17(i) Reporting
Provides format and information for a request for an extension of a temporary marketing permit.
2. Purpose
and Use of the Information Collection
Any
interested person (institutional customer, industrial customer, or
food industry member, i.e., manufacturer, packer, or distributor)
desiring to apply for a temporary marketing permit must file a
written application, at any time, responding to §130.17. After
the information in the application is received by FDA, it is reviewed
to assure that it is sufficient. When information is lacking, the
applicant is promptly contacted and told of the deficiencies. When
the information received warrants the issuance of a permit, a letter
granting the permit is issued to the applicant and a notice of
issuance of the permit is published in the Federal Register.
The industry is aware that the issuance of a temporary marketing permit is contingent upon the submission of finished labels. Thus, the industry's labeling of an experimental food not only alerts consumers that the food may vary from their expectations of the standardized food, but also protects consumers against false and misleading labeling.
The penalties for shipping foods that deviate from their applicable standards without an approved temporary marketing permit are seizure and injunction, as well as criminal actions such as fines and imprisonment.
Description of Respondents: The likely respondents include businesses manufacturing, packing, or distributing food sold in the United States. Respondents are from the private sector (for-profit businesses).
3. Use
of Improved Information Technology and Burden Reduction
Industry
is increasingly turning to the use of automatic production
facilities. The use of automated printouts is acceptable for
purposes of evaluating new food products prior to submitting a
petition to amend a standard. Any use of improved technology
appropriate to satisfy FDA regulation is acceptable. Firms
may submit temporary marketing permit applications by e-mail. The
agency estimates that about twenty-five percent (25%) of the
temporary marketing
permit applications
will be submitted electronically in the next three years.
4. Efforts
to Identify Duplication and Use of Similar Information
FDA
is the only Federal agency with the authority to issue temporary
marketing permits for market testing of experimental foods under FDA
jurisdiction. No similar information collection requirement exists.
5. Impact on Small Businesses or Other Small Entities
FDA
estimates that ten percent (10 %) of respondents are small
businesses. The reporting requirements of these regulations are
mandated by the act and there is no statutory exception for small
businesses. FDA aids
small businesses in complying with its requirements through the
agency’s Regional Small Business Representatives and through
the scientific and administrative staffs within the agency. FDA has
provided a Small Business Guide on the agency’s website at
http://www.fda.gov/oc/industry/.
6. Consequences
of Collecting the Information Less Frequently
Data
collection occurs occasionally.
There are no consequences to Federal program or policy activities if
the information is not collected or is collected less frequently.
However, information generated under temporary marketing permits on
the acceptability of the variation in the standardized food is an
important factor in the agency's decision on whether to propose to
amend the applicable standard of identity to provide for the
variation.
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 10, 2011 (76 FR 34080).
No comments
were received. FDA communicates regularly with firms that have
submitted recent requests for temporary marketing permits. None of
these firms had comments concerning the provisions of § 130.17.
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:
Table 1.--Estimated Annual Reporting Burden1 |
|||||
21 CFR Section |
No. of Respondents |
No. of Responses per Respondent |
Total Annual Responses |
Average Burden per Response |
Total Hours |
130.17(c) |
13 |
2 |
26 |
25 |
650 |
130.17(i) |
1 |
2 |
2 |
2 |
4 |
Total |
|
|
|
|
654 |
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated number of temporary marketing permit applications and hours per response is an average based on the Agency's experience with applications received for the past 3 years, and information from firms that have submitted recent requests for temporary marketing permits. Based on this information, we estimate that there will be, on average, approximately 13 firms submitting requests for two temporary marketing permits per year over the next 3 years.
Thus, FDA estimates that 13 respondents will submit 2 requests for temporary marketing permits annually under § 130.17(c). The estimated number of respondents for § 130.17(i) is minimal because this section is seldom used by the respondents; therefore, the Agency estimates that there will be one or fewer respondents annually with two or fewer requests for extension of the marketing permit under § 130.17(i). The estimated number of hours per response is an average based on the Agency's experience and information from firms that have submitted recent requests for temporary marketing permits. We estimate that 13 respondents each will submit 2 requests for temporary marketing permits under § 130.17(c) and that it will take a respondent 25 hours per request to comply with the requirements of that section, for a total of 650 hours. We estimate that one respondent will submit two requests for extension of its temporary marketing permits under § 130.17(i) and that it will take a respondent 2 hours per request to comply with the requirements of that section, for a total of 4 hours.
12 b. Annualized Cost Burden Estimate
The annual hour cost burden to respondents is approximately $ 55,799.28 per year. FDA estimates that the average hourly wage for the employee preparing and submitting the temporary marketing permit application would be equivalent to a GS-13/Step-1 level in the locality pay area of Washington-Baltimore in 2011, approximately $42.66/hour. Doubling this wage to account for overhead costs, FDA estimates the average hourly cost to respondents to be $85.32/hour. Thus, the overall estimated cost incurred by the respondents is $55,799.28 (654 burden hours x $85.32/hr = $55,799.28.
13. Estimates
of Other Total Annual Cost Burden to Respondents and Record
Keepers
There
are no capital, start-up, operating, or maintenance costs associated
with this collection.
14. Annualized
Cost to Federal
Government
FDA
estimates that approximately 0.4 of a professional person per year is
used annually to process applications for temporary marketing
permits. The salaries of the professionals involved are estimated to
average approximately $84,855 per year. Therefore, about $33,942 per
year (0.4 X $84,855) is spent on professional salaries alone. This
estimate also presumes that overhead will be equal to salary for a
total cost to the Federal Government to process applications for
temporary marketing permits of approximately $67,884 per year.
15. Explanation
for Program Changes or Adjustments
There
was no change in the burden estimate.
16. Plans for Tabulation and Publication and Project Time Schedule
The
agency has no plans for publication of information from this
information collection. However,
the issuance of a temporary marketing permit is announced in the
Federal Register.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Approval
to not display the expiration date for OMB approval of the
information collection is not being sought.
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 | 2011-08-23 |
| File Created | 2011-08-23 |