70 FR 67 pg. 18029 - Agency Information Collection Activities; Submission for Office ofManagement and Budget Review; Comment Request; Temporary Marketing PermitApplications
Type: NOTICEVolume: 70Number: 67Page: 18029
Docket number: [Docket No. 2005N-0564]
FR document: [FR Doc. 05-7021 Filed 4-7-05; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0564]
Agency Information Collection Activities; Submission for Office ofManagement and Budget Review; Comment Request; Temporary Marketing PermitApplications
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) isannouncing that a proposed collection of information has been submitted tothe Office of Management and Budget (OMB) for review and clearance underthe Paperwork Reduction Act of 1995.
DATES:
Fax written comments on the collection ofinformation by May 9, 2005.
ADDRESSES:
OMB is still experiencing significant delaysin the regular mail, including first class and express mail, and messengerdeliveries are not being accepted. To ensure that comments on theinformation collection are received, OMB recommends that comments be faxedto the Office of Information and Regulatory Affairs, OMB, Attn: FumieYokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins,Office of Management Programs (HFA-250), Food and DrugAdministration, 5600 Fishers Lane, Rockville, MD 20857,301-827-1223.
SUPPLEMENTARY INFORMATION:
In compliance with 44 U.S.C. 3507, FDA has submitted the followingproposed collection of information to OMB for review and clearance.
Temporary Marketing Permit Applications-21 CFR 130.17(c) and (i)(OMB Control Number 0910-0133)-Extension
Section 401 of the Federal Food, Drug, and Cosmetic Act (the act) (21U.S.C. 341), directs FDA to issue regulations establishing definitions andstandards of identity for food "[w]henever * * * suchaction will promote honesty and fair dealing in the interest of consumers* * * ". Under section 403(g) of the act (21 U.S.C.343(g)), a food that is subject to a definition and standard of identityprescribed by regulation is misbranded if it does not conform to suchdefinition and standard of identity. Section 130.17 (21 CFR 130.17)provides for the issuance by FDA of temporary marketing permits that enablethe food industry to test consumer acceptance and measure the technologicaland commercial feasibility in interstate commerce of experimental packs offood that deviate from applicable definitions and standards of identity.Section 130.17(c) enables the agency to monitor the manufacture, labeling,and distribution of experimental packs of food that deviate fromapplicable definitions and standards of identity. The information soobtained can be used in support of a petition to establish or amend theapplicable definition or standard of identity to provide for thevariations. Section 130.17(i) specifies the information that a firm mustsubmit to FDA to obtain an extension of a temporary marketing permit.
In the Federal Register of January 13, 2005 (70 FR 2411),FDA published a 60-day notice requesting public comment on the informationcollection provisions. No comments were received.
FDA estimates the burden of the collection of information asfollows:
| 21 CFR section | Number of Respondents | Annual Frequency per Response | Total Annual Responses | Hours per Response | Total hours |
|---|---|---|---|---|---|
| 130.17(c) | 3 | 2 | 6 | 25 | 150 |
| 130.17(i) | 4 | 2 | 8 | 2 | 16 |
| Total | 166 | ||||
| 1 There are no capital costs or operating and maintenancecosts associated with this collection of information. | |||||
The estimated number of temporary marketing permit applications andhours per response is an average based on the agency's experience withapplications received October 1, 2001, through September 30, 2004, andinformation from firms that have submitted recent requests for temporarymarketing permits.
Dated: April 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7021 Filed 4-7-05; 8:45 am]
BILLING CODE 4160-01-S