0275 Supporting Statement May 2015

State Enforcement Notifications
OMB Control No. 0910-0275
SUPPORTING STATEMENT
A. Justification
1. Circumstances Making the Collection of Information Necessary
Section 310(b) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 337(b))
authorizes a State to enforce certain sections of the FD&C Act in their own name and within their
own jurisdiction. However, before doing so, a State must provide notice to FDA according to 21
CFR 100.2. The information required in a letter of notification under § 100.2(d) enables us to
identify the food against which a State intends to take action and to advise that State whether
Federal enforcement action against the food has been taken or is in process. With certain narrow
exceptions, Federal enforcement action precludes State action under the FD&C Act.
This is a request for extension by OMB of its approval of the information collection requirements in
the following citation:
21 CFR 100.2(d) - Reporting
Describes the information to be in a notification from a State advising FDA of the State's intent to
initiate an enforcement action against a food under certain sections of the FD&C Act.
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 States that enforce certain sections of the FD&C
Act relating to misbranding of foods and food standards of identity. Respondents are State
governments.
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.
FDA estimates that about fifty percent (50%) of the notices of State enforcement action will be
submitted electronically in the next three years.

4. Efforts to Identify Duplication and Use of Similar Information
The notification provisions of 21 CFR 100.2(d) prevent State duplication of an FDA enforcement
action against a food for certain violations of the FD&C Act. The notification provisions are
limited to certain labeling requirements of the FD&C Act that are enforced by FDA. Because
Federal enforcement of these provisions is exclusive to FDA, there is no likelihood of enforcement
duplication by other Federal agencies.
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), a 60-day notice for public comment was published in the
Federal Register on March 13, 2015 (80 FR 13392). 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 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.
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12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
Description of Respondents: The respondents are States that enforce certain sections of the FD&C
Act relating to misbranding of foods and food standards of identity. Respondents are State
governments.
FDA estimates the burden of this collection of information as follows:
Estimated Annual Reporting Burden1
21 CFR
Section

1

No. of
Respondents

No. of
Responses
per
Respondent

Total Annual
Responses

Average
Burden
per
Response

Total Hours

1
1
1
10
10
100.2(d)
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.
12 b. 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 $732. 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 2015, which makes the annual wage cost for
completion and submission approximately $366 (10 hours x $36.60 per hour). To account for
overhead, this cost is increased by 100 percent, making the total estimated burden hour cost to the
respondent $732.
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 the annualized cost to the Federal government for the review and evaluation of
enforcement notifications submitted under section 21 CFR 100.2(d) is approximately $3,481.60.
This is based on the assumption that review and evaluation by a Federal employee will take about
40 hours per notification at $43.52 per hour (the GS-13/Step-1 salary rate for the WashingtonBaltimore locality pay area for the year 2015). Thus, the wage cost to the Federal government for
review and evaluation of notifications would be $1,740.80 (40 hours x $ 43.52 per hour). To
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account for overhead, this cost is increased by 100 percent, making the total estimated cost to the
Federal government $3,481.60.
15. Explanation for Program Changes or Adjustments
The hour burden is unchanged.
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.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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