STATE PETITIONS FOR EXEMPTION FROM PREEMPTION
SUPPORTING STATEMENT
1. Circumstances
Making the Collection of Information Necessary
Under section 403A(b) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343-1(b)), States may petition FDA for exemption from Federal preemption of State food labeling and standard of identity requirements. Section 100.1(d) (21 CFR 100.1(d)) sets forth the information a State is required to submit in such a petition. The information required under § 100.1(d) enables FDA to determine whether the State food labeling or standard of identity requirement satisfies the criteria of section 403A(b) of the act for granting exemption from Federal preemption.
FDA is requesting extension of OMB approval for the information collection requirements in the following citation:
21 CFR 100.1(d)- Reporting
Sets forth data requirements for State petitions requesting exemption from Federal preemption.
2. Purpose
and Use of the Information Collection
States
seeking exemption from Federal preemption of State food labeling and
standard of identity requirements may submit a petition to FDA under
§ 100.1(d). The information required under §100.1(d)
enables FDA to determine whether the State food labeling or standard
of identify requirement satisfies the criteria of section 403A(b) for
granting exemption from preemption. In the last three years, FDA has
received no petitions from State agencies seeking exemption from
Federal preemption.
3. Use
of Improved Information Technology and Burden Reduction
Section
100.1(d) does not prescribe the use of automated, electronic,
mechanical, or other technological techniques of other forms of
information technology as necessary for use by the States. States
are free to use whatever form of information technology may best
assist them in the development of their petition.
4. Efforts
to Identify Duplication and Use of Similar Information
No
Federal duplication of information collection is likely because State
petitions submitted under
§ 100.1(d) apply only to statutes and regulations administered
by FDA. States would not be required to submit duplicative petitions
with any other Federal agencies.
5. Impact on Small Businesses or Other Small Entities
The
provisions of this regulation are specific to State and local
governments and are not applicable to small businesses.
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.
7. Special
Circumstances
Relating to the
Guidelines of 5 CFR 1320.5
None
of the requirements are inconsistent with the guidelines in 5 CFR
1320.5.
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 March 4, 2008 (73 FR
11648). No comments were received.
12. Estimates
of Annualized Burden Hours and Costs
Description of Respondents: respondents to this collection of information are State governments.
FDA estimates the burden of this collection of information as follows:
Estimated Annual Reporting Burden1 |
|||||
21 CFR Section |
No. of Respondents |
Annual Frequency per Response |
Total Annual Responses |
Hours per Response |
Total Hours |
100.1(d) |
1 |
1 |
1 |
40 |
40 |
1There are no capital costs or operating and maintenance costs associated with this collection of information.
The reporting burden for §100.1(d) is minimal because petitions for exemption from preemption are seldom submitted by States. In the last 3 years, FDA has not received any new petitions for exemption from preemption; therefore, the agency estimates that one or fewer petitions will be submitted annually. Although FDA has not received any new petitions for exemption from preemption in the last 3 years, it believes these information collection provisions should be extended to provide for the potential future need of a State or local government to petition for an exemption from preemption under the provisions of section 403(A) of the act.
Estimated Annualized Cost for the Burden Hours
FDA estimates that the annualized hour burden cost to respondents for completion and submission will be insignificant.
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
In
the event that a petition is submitted under §100.1(d), FDA
estimates that the annualized cost to the Federal government for the
review and evaluation of such a petition would be $1,590. The cost
is estimated as being equivalent to 40 hours of review and evaluation
per year at a GS-13/Step-1 salary rate of $39.75/hr for the
Washington-Baltimore locality pay area for the year 2008 (40 hours x
$39.75/hour = $1,590).
15. Explanation
for Program Changes or Adjustments
The
hour burden is unchanged.
16. Plans for Tabulation and Publication and Project Time Schedule
The agency has no plans for publication of information from this information collection.
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 | 2008-06-06 |
File Created | 2008-06-06 |