0275 SSA 2018 Ext

United States Food and Drug Administration
State Enforcement Notifications
OMB Control No. 0910-0275
SUPPORTING STATEMENT Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, us or we)
regulations. Section 403A(b) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act, the act) provides that, where a State requirement has been preempted under section
403A(a) of the act, the State may petition the agency for an exemption from preemption.
If the Food and Drug Administration (FDA, us or we) finds that the State requirement
will not cause any food to be in violation of any applicable requirement under Federal
law, will not unduly burden interstate commerce, and is designed to address a particular
need for information that is not met by the preemptive Federal requirement, the
exemption from preemption may be granted. A State may also bring civil enforcement
proceedings on its on behalf under for violations of certain sections of the act in
accordance with Section 310.
Regulations found at 21 CFR Part 100 establish submission and consideration
requirements for both petitions under section 403A(a) of the act, and notifications
prescribed under Section 310. Information collection provisions associated with
preemption petitions are found in 21 CFR Part 100.1 and are approved under OMB
Control No. 0910-0277. Regulations at 21 CFR 100.2 set forth notification requirements
associated with State enforcement proceedings and explain certain limitations. With
narrow exceptions, Federal enforcement action precludes State action under the FD&C
Act.
We therefore request extension of OMB approval for the information collection
provisions found under 21 CFR Part 100.2: State Enforcement of Federal Regulations,
and discussed in this supporting statement.
2. Purpose and Use of the Information Collection
Section 310(b) of the FD&C Act provides that States must give notice to FDA before
taking action to enforce certain provisions of the food misbranding provisions of the
FD&C Act. This information will be used by the agency in reaching a conclusion as to
whether Federal action is being or will be taken against the same product that is under
consideration for action by the State.
Description of Respondents: The respondents are State governments that enforce certain
sections of the FD&C Act relating to misbranding of foods and food standards of
identity.

3. Use of Improved Information Technology and Burden Reduction
The regulation (21 CFR 100.2) for State notices of enforcement actions does not
specifically prescribe the use of automated, electronic, mechanical or other technological
techniques or other forms of information technology as necessary for use by the States.
States are free to use whatever forms of information technology may best assist them in
their development of a notice. We estimate any notifications received in the next three
years will be submitted electronically.
4. Efforts to Identify Duplication and Use of Similar Information
Notifications under 21 CFR 100.2(d) should prevent State duplication of an FDA
enforcement action against a food for certain violations of the FD&C Act. Also, we note
that provisions set forth under 21 CFR 100.1 and covered under OMB Control No. 09100277 may be appropriately consolidated with this information collection. We are
otherwise unaware of duplication.
5. Impact on Small Businesses or Other Small Entities
The provisions of 21 CFR 100.2(d) are specific to State governments and are not
applicable to small businesses. FDA estimates that zero percent (0%) of respondents are
small businesses.
6. Consequences of Collecting the Information Less Frequently
Data collection occurs occasionally. 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
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 February 7, 2018 (83 FR 5438). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
FDA does not provide any payments or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents
State notification letters submitted to FDA under section 310(b) of the FD&C Act will
contain information compiled for law enforcement purposes and may contain trade

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secrets or confidential commercial or financial information. Accordingly, 21 CFR
100.2(i) provides that information contained in the required notification letters will be
exempt from public disclosure to the same extent to which such information would be
exempt under 21 CFR 20.61, 20.64, and 20.88. This information is also safeguarded by
section 301(j) of the FD&C Act and would be protected from disclosure under the
Freedom of Information Act (FOIA) under sections 552(a) and (b) (5 U.S.C. 552(a) and
(b)).
11. Justification for Sensitive Questions
This information collection does not involve any questions that are of a personally
sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
FDA estimates the burden of this collection of information as follows:
21 CFR Section
100.2(d)
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Table 1.--Estimated Annual Reporting Burden1
No. of
No. of
Total
Average
Respondents
Responses per
Annual
Burden per
Respondent
Responses
Response
1
1
1
10

Total
Hours
10

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

The estimated reporting burden for 21 CFR 100.2(d) is minimal because enforcement
notifications are seldom used by States. During the last 3 years, we have not received
any new enforcement notifications; therefore, we estimate that one or fewer notifications
will be submitted annually.
Although we have not received any new enforcement notifications in the last 3 years, we
believe these information collection provisions should be extended to provide for the
potential future need of a State government to submit enforcement notifications
informing us when it intends to take enforcement action under the FD&C Act against a
particular food located in the State.
12b. Annualized Cost Burden Estimate
FDA estimates the annualized burden hour cost to a respondent for completion and
submission of an enforcement notification to be approximately $780. FDA estimates that
a State administrator’s average wage to be that of a Federal government employee at the
GS-12/Step-1 rate for the Washington-Baltimore locality pay area for the year 2018,
which makes the annual wage cost for completion and submission approximately $390
(10 hours x $39.07 per hour). To account for overhead, this cost is increased by 100
percent, making the total estimated burden hour cost to the respondent $780.

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Type of
Respondent
State administrator

Total Burden
Hours
10

Hourly Wage Rate
$78.00

Total Respondent
Costs
$780

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
information collection.
14. Annualized Cost to the Federal Government
We estimate an annualized cost to the Federal government attributable to the review and
evaluation of enforcement notifications submitted under section 21 CFR 100.2(d) to be
approximately $3,716.80. This figure assumes that review and evaluation by a Federal
employee takes about 40 hours per notification at $46.46 per hour (the GS-13/Step-1
salary rate for the Washington- Baltimore locality pay area for the year 2018). However,
as stated previously, no notifications have been received since last OMB review of the
information collection.
15. Explanation for Program Changes or Adjustments
We retain the currently approved burden estimate for the information collection.
16. Plans for Tabulation and Publication and Project Time Schedule
The information obtained from this data collection will not be published.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
No approval is requested to not display the expiration date of OMB approval.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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