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 (21 CFR 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.
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.
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
The
same information is requested from large and small firms and is the
minimal amount needed. There is no special burden placed on small
businesses by this regulation. To exempt a small business would only
hurt that business since it could not market test an experimental
food. The agency, however, does have an office of Small
Manufacturers Assistance which may be contacted if help is needed.
6.
Consequences of Collecting
the Information Less Frequently
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 information
collection.
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 5,
2014 (79 FR 32556). 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.
Table 1 -- Estimated Annual Reporting Burden1 |
|||||
21 CFR Section/ Activity |
No. of Respondents |
No. of Responses per Respondent |
Total Annual Responses |
Avg. Burden per Response (in Hours) |
Total Hours |
130.17(c); permit request |
13 |
2 |
26 |
25 |
650 |
130.17 (i); extension request |
1 |
2 |
2 |
2 |
4 |
Total |
654 |
||||
We estimate the burden of this collection of information as follows:
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 and information from firms that have submitted recent requests for temporary marketing permits. Based upon this prior history, we estimate that, on an annual basis, we will receive approximately 26 temporary marketing permits from 13 applicants and 2 requests for extensions from 1 applicant. The burden for these applications is approximately 654 hours.
12 b. Annualized Cost Burden Estimate
We estimate the annualized burden hour cost to respondents for this collection of information to be approximately $56,361.72. We estimate that this collection of information will involve an employee making an average wage similar that of a Federal government employee at the GS-13/Step-1 rate for the Washington-Baltimore locality pay area for the year 2014, which is $43.09 per hour. To account for overhead, this cost is increased by 100 percent, which is $86.18 per hour. Thus, the annual wage cost imposed by this collection of information is approximately $56,361.72 (654 hours x $86.18 per hour).
13.
Estimates of Other Total Annual Cost Burden to Respondents and
Record Keepers
There
are no capital costs or operating and maintenance costs associated
with this collection.
14.
Annualized Cost
to Federal Government
We
estimate 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 $80,662 per year (equivalent to
a GS-12/Step-3 rate for the Washington-Baltimore locality pay area
for the year 2014).
Therefore, about $32,265 per year (0.4 x $80,662) is spent on
professional salaries alone.
To account for overhead, this cost is increased by 100 percent.
Thus, we estimate the annual cost to the Federal government to be
$64,530 ($32,265 x 2).
15.
Explanation for Program Changes or Adjustments
The
burden estimate remains unchanged.
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
No
exceptions are requested.
| File Type | application/msword |
| File Title | Supporting Statement for |
| Author | Joanna Capezzuto |
| Last Modified By | Bean, Domini |
| File Modified | 2014-09-10 |
| File Created | 2014-09-10 |