**SUPPORTING STATEMENT**

**Applications for Temporary Marketing Permits**

**(21 CFR 130.17(c) and (i)**

**OMB No. 0910-0133**

A. **JUSTIFICATION**

1\. **Necessity for the Information Collection**

> Section 401 of the Federal Food, Drug, and Cosmetic Act (the 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.\'\' These actions, intended to resolve economic problems,
> may result from petitions from consumer groups, the food industry, or
> interested persons, or from the agency=s own initiative. Under section
> 403(g) of the 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 (Attachment A).
>
> To enable the food industry to obtain data in support of petitions to
> amend food standards, FDA issues temporary marketing permits for
> interstate shipment of experimental packs of food varying from
> requirements of standards of identity, in accordance with the
> regulation in \'130.17 (21 CFR 130.17) (Attachment B). This regulation
> allows a manufacturer, packer, or distributor, etc., to conduct
> investigations of a potential advance in food technology to determine
> the advantages to, and acceptance by, consumers of a variation in a
> food from an applicable standard of identity.
>
> 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\. **How, by Whom, and for What Purpose Information is Used**

> 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**

> 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\. **Identification of Duplication and Similar Information Already
Available**

> 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\. **Small Business**

> 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. Of the approximately 6 companies per year that request temporary
> marketing permits, only 1 or 2 could be considered to be small
> companies. The agency, however, does have an office of Small
> Manufacturers Assistance which may be contacted if help is needed.

6\. **Consequences if Data Were Collected 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**

> There are no special circumstances associated with this information
> collection.

8\. **Outside Consultation**

> FDA contacted a sampling of firms that have submitted recent requests
> for temporary marketing permits. None of these firms had comments
> concerning the provisions of \' 130.17.
>
> In accordance with 5 CFR 1320.8(d), on January 13, 2005 (70 FR 2411),
> a 60-day notice for public comment (Attachment C) was published in the
> Federal Register. No comments were received from the public.

9\. **Gifts**

> This information collection does not provide for payment or gifts to
> respondents.

10\. **Confidentiality**

> 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.

11\. **Sensitive Questions**

> This information collection does not involve any questions of a
> sensitive nature.

12\. **Respondent Hour Burden and Annualized Burden Hour Costs**
**Estimates**

> [Burden Hours]{.underline}.
>
> The annual burden hour for this information collection is 304 hours,
> as follows:

  ------------------------------------------------------------------------------
  Estimated                                                            
  Annual                                                               
  Reporting                                                            
  Burden                                                               
  ----------- -------------- --------------- ----------- ------------- ---------
  21 CFR      No. of         Annual          Total       Hours per     Total
  Section     Respondents    Frequency per   Annual      Response      Hours
                             Response        Responses                 

  130.17(c)   3              2               6           25            150
  ------------------------------------------------------------------------------

  ----------- -------------- --------------- ---------- ------------- ---------
  130.17(i)   4              2               8          2             16

  Total                                                               166
  ----------- -------------- --------------- ---------- ------------- ---------

> [Estimated Annualized Cost for the Burden Hours]{.underline}.
>
> The estimated number of temporary marketing permit applications and
> hours per response is an average based on the agency=s experience with
> applications received from October 1, 2001, through September 30, 2004
> and information from firms that have submitted recent requests for
> temporary marketing. During that period FDA received a total of 9
> requests for temporary marketing permits under 130.17(c) from a total
> of 8 applicants. During that same period, FDA received a total of 12
> requests for temporary marketing permit extensions under 130.17(i)
> from a total of 10 applicants. Based upon this prior history, FDA
> estimates that it will receive approximately 3 temporary marketing
> permits and 4 requests for extensions annually from 3 and 4 applicants
> respectively. The burden for these applications is approximately 166
> hours.
>
> FDA estimates the annualized cost to respondents for the hour burden
> associated with the requirements of this regulation to be
> approximately \$21,319. This estimate presumes that the hourly cost to
> affected firms will not exceed the base hourly rate of a GS-13 salary
> (\$34.61) plus overhead expenses estimated as being equal to salary,
> or \$69.22.

13\. **Annual Cost Burden to Respondent**

> There are no capital costs or operating and maintenance costs
> associated with this collection.

14\. **Annualized Cost to the 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 \$72,000 per year. Therefore, about \$28,800 per
> year (0.4 X \$72,000) is spent on professional salaries alone. The
> cost is estimated as being equivalent to the number of hours of review
> and evaluation per year for temporary marketing permits at a
> GS-13/Step 1 salary rate of \$34.61/hour for the Washington-Baltimore
> locality pay area for year 2004. 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 \$57,600 per year.

15\. **Changes or Adjustments in Burden**

> The decrease in the total burden reflected in this statement (25
> hours) reflects a slight decrease in the number of applications and
> applicants.

16. **Statistical Analysis, Publication Plans, and Schedule**

Not applicable.

17\. **Approval Not to Display Expiration Date**

> There are no reasons why display of the expiration date for OMB
> approval of the information collection would be inappropriate.

18\. **Exception to the Certification Statement Identified in Item 19**

> No exceptions to the certification statement identified in item 19 of
> the instructions for completing OMB form 83-1 have been identified.

**B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS**

> There are no plans to publish the information collected under the
> provisions of this regulation for statistical use. The collection of
> information required under the provisions of this regulation does not
> employ statistical methods.