SUPPORTING STATEMENT
Terms of Clearance: None.
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:
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.
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.
FDA does not provide any payments or gifts 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.
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.
| File Type | application/msword |
| File Title | Supporting Statement for |
| Author | Joanna Capezzuto |
| Last Modified By | Capezzuto, JonnaLynn |
| File Modified | 2012-03-15 |
| File Created | 2012-03-15 |