0545 CVM amendment Part A ss 5-19-08

0545 CVM amendment Part A ss 5-19-08.doc

Health and Diet Survey

OMB: 0910-0545

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SUPPORTING STATEMENT


Health and Diet Survey; Pet Food Labeling Survey

OMB No. 0910-0545 – PART A



A. Justification


1. Circumstances Making the Collection of Information Necessary

On September 28, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA). Section 1002 (a) of FDAAA requires, among other things, that FDA establish, “by regulation,” standards for labeling of pet food, including nutritional and ingredient information. The Center for Veterinary Medicine (CVM), FDA, seeks to establish baseline information about consumer use and understanding of pet food labels. The survey module would be repeated after the new pet food label regulations are implemented to estimate changes in consumer beliefs and behavior about pet food labels. FDA is required to implement the pet food labeling regulations by September 2009. Due to the short time frame, the Center for Food Safety and Applied Nutrition’s (CFSAN) Health and Diet Survey (HDS) (0910-0545) could serve as a vehicle for accomplishing this goal. CVM and CFSAN would like to modify the existing information collection request, currently at the Office of Management and Budget for renewal, to include a new module on pet food labeling.



2. Purpose and Use of the Information Collection

CVM seeks the information to establish baseline estimates of consumer use of current pet food labels. The data can be used to evaluate and track changes in consumer behavior and understanding of pet food label usage after implementation of new regulations. The data will also be used to inform future research on standardized pet food labels.

3. Use of Improved Information Technology and Burden Reduction

Refer to the Health & Diet Survey (0910-0545).



4. Efforts to Identify Duplication and Use of Similar Information

There is no duplicative collection of this information. No comparable data are collected by any other means.



5. Impact on Small Businesses or Other Small Entities

The collection of information will not involve small businesses.

6. Consequences of Collecting the Information Less Frequently

If this information is collected less frequently, current, essential, and national data of consumer knowledge, perceptions, attitudes, and practices pertinent to pet food labels will not be available to the FDA. The lack of information will severely limit the agency's capabilities in performing its functions properly to promote and protect public and animal health.


7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

Refer to the Health & Diet Survey (0910-0545).

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

Not applicable.


9.
Explanation of Any Payment or Gift to Respondents

Respondents will not receive any type of payment or gift for participation in this collection of information.

10. Assurance of Confidentiality Provided to Respondents

Refer to the Health & Diet Survey (0910-0545).



11. Justification for Sensitive Questions

No sensitive information will be collected with respect to pet food label usage and understanding.



12. Estimates of Annualized Burden Hours and Costs


Description of Respondents: The respondents are adults, age 18 and older, drawn from the 50 states and the District of Columbia. Participation will be voluntary.


FDA estimates the burden of this collection of information as follows:


Table 1.--Estimated Annual Reporting Burden1

Statutory Authority

No. of Respondents

Annual Frequency per Response

Total Annual Responses

Hours per Response

Total Hours

P.L. 110-85

Sect. 1002(a)(3)

1000

1

1000

0.08

80

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


This burden estimate does not represent a new estimate of burden hours. Instead, it represents the estimated number of respondents and burden hours that will be used from the current approval for 0910-0545 to conduct the pet food labeling questions. The total estimated burden for 0910-0545 is 1,300 hours.


Costs to Respondents. There is no additional cost incurred by respondents to the pet food label questions beyond the cost of the Health and Diet Survey (0910-0545).


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


There is no additional cost incurred to the Federal Government for the pet food label questions beyond the cost of the Health and Diet Survey (0910-0545).


15. Explanation for Program Changes or Adjustments

The addition of the pet food label questions to 0910-0545 does not result in program changes or adjustments.


16. Plans for Tabulation and Publication and Project Time Schedule


The time schedule for the Health and Diet Survey- Pet Food Labeling Survey will be the same as that for the Health & Diet Survey (0910-0545).


17. Reason(s) Display of OMB Expiration Date is Inappropriate


No exemption is requested.


18. Exceptions to Certification for Paperwork Reduction Act Submissions

No exceptions are requested.









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File Typeapplication/msword
File TitleSupporting Statement for
AuthorJoanna Capezzuto
Last Modified ByJonna Capezzuto
File Modified2008-05-19
File Created2008-05-19

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