SUPPORTING STATEMENT
1. Circumstances
Making the Collection of Information Necessary
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 “[w]henever * * * such action
will promote honesty and fair dealing in the interest of consumers *
* *.” 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. 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 April
2, 2008 (73 FR 17986). 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.
Total Estimated Annual Reporting Burden1 |
|||||
21 CFR Section |
No. of Respondents |
Annual Frequency per Response |
Total Annual Responses |
Hours 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 October 1, 2004, through September 30, 2007, and information from firms that have submitted recent requests for temporary marketing permits. Based upon this prior history, FDA estimates that, on an annual basis, it will receive approximately 2 temporary marketing permits from 13 applicants and 2 requests for extensions from 1 applicant. The burden for these applications is approximately 654 hours.
Estimated Annualized Cost for the Burden Hours
FDA estimates the annualized cost to respondents for the hour burden associated with the requirements of this regulation to be approximately $49,926.36. This estimate presumes that the hourly cost to affected firms will not exceed the base hourly rate of a GS-13 salary ($38.17) plus overhead expenses estimated as being equal to salary, or $76.34. Thus, 654 hours x $76.34 per hour equals $49,926.36
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
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 $79,397 per year. Therefore, about $31,759
per year (0.4 X $79,397) 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 $63,518 per year.
15. Explanation
for Program Changes or Adjustments
The
increase in the estimated reporting burden is due primarily to an
increase in the estimated number of applications for temporary
marketing permits.
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 | Jonna Capezzuto |
| File Modified | 2008-06-24 |
| File Created | 2008-06-24 |