0275 State enforcement notifications SSA 2024 Ext

UNITED STATES FOOD & 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. Specifically, section 310(b) of the Federal Food, Drug, and Cosmetic Act (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.

We therefore request extension of OMB approval for the information collection provisions found under 21 CFR 100.2: State Enforcement of Federal Regulations, as 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 us 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 (§ 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 (e.g., 100%) in the next three years will be submitted electronically via email.

4. Efforts to Identify Duplication and Use of Similar Information

We are unaware of duplicative information collection. Notification provisions of § 100.2(d) should 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 § 100.2(d) are specific to State governments and are not applicable to small businesses. We estimate that none of the respondents are small businesses.

6. Consequences of Collecting the Information Less Frequently

The information collection schedule is consistent with statutory and regulatory authorities. 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), we published a 60-day notice for public comment in the Federal Register of January 23, 2024 (89 FR 4315). No comments were received.

9. Explanation of Any Payment or Gift to Respondents

No payments or gifts are provided to respondents to the collection of information.

10. Assurance of Confidentiality Provided to Respondents

The Privacy Act of 1974

In preparing this supporting statement, we consulted with our Privacy Office to ensure appropriate handling of information collected. This ICR collects personally identifiable information (PII) that supports an FDA regulation: § 100.2; as well as section 403A(b) of the FD&C Act. PII is collected in the context of the subject individuals’ professional capacity and the FDA-related work performed for their employer (e.g., point of contact at a regulated entity). The PII submitted is reporting official and agency contact name, title, work telephone number, work address, and fax telephone number. We have determined that although PII is collected, the collection is not subject to the Privacy Act of 1974 and the particular notice and other requirements of the Privacy Act do not apply. Specifically, the contractor or FDA does not use name or any other personal identifier to retrieve records from the information collected.

The Freedom of Information Act (FOIA)

Under FOIA (5 U.S.C. 552), the public has broad access to government documents. However, FOIA provides certain exemptions from mandatory public disclosure of government records (5 U.S.C. 552(b)(1-9)). We will make the fullest possible disclosure of records to the public, consistent with the rights of individuals to privacy, the property rights of persons in trade and confidential commercial or financial information. 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, § 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 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 Cost

12a. Annualized Hour Burden Estimate

Table 1.--Estimated Annual Reporting Burden1
21 CFR Section; Activity	No. of Respondents	No. of Responses per Respondent	Total Annual Responses	Average Burden per Response	Total Hours
100.2(d)	1	1	1	10	10

¹There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimated reporting burden for § 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, these information collection provisions should be extended to provide for the potential future need of a State government to submit an enforcement notification 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

We estimate the annualized cost burden for completion and submission of an enforcement notification to be $950.60. We assume that a State administrator’s average wage to be commensurate with the wage of a Federal government employee at the GS-12/Step-1 rate for the Washington-Baltimore locality pay area for the year 2024. We calculate annual costs by multiplying the wage rate by the annual burden hours (10 hours x $47.53 per hour = $475.30), and increasing the total by 100 percent to account for overhead costs.

Table 2.--Annual Cost Burden Estimate

Type of Respondent	Total Burden Hours	Fully Loaded Hourly Wage Rate	Total Respondent Costs
State administrator	10	$95.06	$950.60

13. Estimates of Other Total Annual Costs to Respondents/Recordkeepers or 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 § 100.2(d) to be $4,521.60. We assume that review and evaluation by a Federal employee requires 40 hours per notification at the wage rate of $56.52 per hour (the GS-13/Step-1 salary rate for the Washington- Baltimore locality pay area for the year 2024). To account for overhead, we have doubled the hourly rate to $113.04, which brings the annualized cost to $4,521.60 (40 hours x $113.04/hour). However, as stated previously, no notifications have been received since the last OMB review of the information collection.

15. Explanation for Program Changes or Adjustments

Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate.

16. Plans for Tabulation and Publication and Project Time Schedule

The information obtained from this data collection will not be published or tabulated.

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.