0133 SS Part A Temp Marketing Permits 2017 Extension

United States Food and Drug Administration
Temporary Marketing Permit Applications
OMB Control No. 0910-0133
SUPPORTING STATEMENT Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection request supports Food and Drug Administration regulations.
Specifically, 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 “whenever…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 therefore request OMB approval of the information collection provisions under 21 CFR
§ 130.17, as identified below:
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.
Respondents to this collection of information include the private sector businesses including
institutional and/or industrial customers and food industry members such as manufacturers,
packers, or distributors desiring to apply for a temporary marketing permit or permit
extension.
3. Use of Improved Information Technology and Burden Reduction
Industry is increasingly using 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. FDA estimates that 90% of respondents will use electronic means to satisfy the
information collection provisions found in the regulations.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. FDA is specifically charged with
issuing temporary marketing permits for market testing of experimental foods under its
jurisdiction.
5. Impact on Small Businesses or Other Small Entities
While the regulations provide for no exemptions and some respondents may be small
businesses, FDA aids small businesses through its Regional Small Business Representatives,
Office of Small Manufacturers Assistance, and through the scientific and administrative staffs
within the agency. We have also provided a Small Business Guide on the agency’s website at
https://www.fda.gov/ForIndustry/SmallBusinessAssistance/default.htm .
6. Consequences of Collecting the Information Less Frequently
There are no legal obstacles to reduce the burden for this collection of information. 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.

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7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated for 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 15, 2017 (82 FR 27489). No comments were received in
response to the information collection topics solicited in the notice.
9. Explanation of Any Payment or Gift to Respondents
This information collection does not provide for payment or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents
The existence of the application for a temporary marketing permit is regarded as confidential
commercial information because it would disclose the intent of the company to pursue the
marketing of a new product. Once a notice is published announcing the issuance of the
permit, the application is no longer regarded as confidential. Confidential commercial
information is protected from disclosure under the Freedom of Information Act (FOIA) under
sections 552(a) and (b) (5 U.S.C. 552(a) and (b)), and by part 20 of the agency’s regulations
(21 CFR part 20).
11. Justification for Sensitive Questions
This information collection does not involve any questions of a sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
We estimate the burden of this collection of information as follows:
Table 1 – Estimated Annual Reporting Burden1
21 CFR Section/
Activity
130.17(c); permit request
130.17(i); extension
request
Total
1

No. of
Respondents

No. of
Responses per
Respondent

13
1

Total
Average
Total
Annual
Burden per Hours
Responses
Response
2
26
25
650
2
2
2
4
654

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

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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 total reporting burden for these applications is 654 hours.
12b. Annualized Cost Burden Estimate
We estimate the annualized burden hour cost to respondents for this collection of information
to be approximately $59,409.36. 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 2017, which is
$45.42 per hour. To account for overhead, this cost is increased by 100 percent, which is
$90.84 per hour. Thus, the annual wage cost imposed by this collection of information is
approximately $59,409.36 (654 hours x $90.84 per hour).
Activity

Total Burden
Hours
Applying for permit 650
Applying for
4
extension
Total

Hourly Wage Rate
$90.84
$90.84

Total Respondent
Costs
$59,046.00
$363.36
$59,409.36

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
We estimate that approximately 0.4 (four tenths) 4 of a professional staff person’s time per
year is used annually to process applications for temporary marketing permits. The salaries of
the professionals involved are estimated to average approximately $85,035 per year
(equivalent to a GS-12/Step-3 rate for the Washington-Baltimore locality pay area for the year
2017). Therefore, $34,014 per year (0.4 x $85,035) is to be spent on professional salaries
alone to process applications for temporary marketing permits. To account for overhead, this
cost is increased by 100 percent. Thus, we estimate the annual cost to the Federal government
to be $68,028 ($34,014 x 2).
15. Explanation for Program Changes or Adjustments
The burden estimate has not changed from our previous estimate. At the same time, we
have we have revised the IC list found at www.reginfo.gov by consolidating the two
previously itemized regulatory provisions by their corresponding subpart in the CFR.
Readers may still view burden associated with each of the individual regulatory
provisions by referring to the tables found at Q.12 of this supporting statement.

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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
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.

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