0275 - Supporting Statement 2012

0275 - Supporting Statement 2012.doc

State Enforcement Notifications

OMB: 0910-0275

Document [doc]
Download: doc | pdf

State Enforcement Notifications

0910-0275


SUPPORTING STATEMENT


Terms of Clearance: None.


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 States to enforce certain sections of the FD&C Act in their own names but provides that States must notify FDA before doing so. Section 100.2(d) (21 CFR 100.2 (d)) sets forth the information that a State must provide to FDA in a letter of notification when it intends to take enforcement action under the FD&C Act against a particular food located in the State. The information required under § 100.2(d) will enable FDA to identify the food against which the State intends to take action and advise the State whether Federal action has been taken against it. 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 November 9, 2011 (76 FR 69742). 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.

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

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

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

1 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, FDA has not received any new enforcement notifications. Therefore, the agency estimates that one or fewer notifications will be submitted annually. Although FDA has not received any new enforcement notifications in the last three years, it believes these information collection provisions should be extended to provide for the potential future need of a State government agency to submit enforcement notifications informing FDA 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 $718. 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 2012, which makes the annual wage cost for completion and submission approximately $359 (10 hours x $35.88 per hour). To account for overhead, this cost is increased by 100 percent, making the total estimated burden hour cost to the respondent $718.


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 $3,412.80. This is based on the assumption that review and evaluation by a Federal employee will take about 40 hours per notification at $42.66 per hour (the GS-13/Step-1 salary rate for the Washington-Baltimore locality pay area for the year 2012). Thus, the wage cost to the Federal government for review and evaluation of notifications would be $1706.40 (40 hours x $ 42.66 per hour). To account for overhead, this cost is increased by 100 percent, making the total estimated cost to the federal government $3,412.80.

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.


4


File Typeapplication/msword
File TitleSupporting Statement for
AuthorJoanna Capezzuto
Last Modified ByCapezzuto, JonnaLynn
File Modified2012-03-15
File Created2012-03-15

© 2024 OMB.report | Privacy Policy