70 FR 67 pgs. 18029-18030 - Agency Information Collection Activities; Submission for Office ofManagment and Budget Review; Comment Request; State Petitions for ExemptionFrom Preemption
Type: NOTICEVolume: 70Number: 67Pages: 18029 - 18030
Docket number: [Docket No. 2004N-0565]
FR document: [FR Doc. 05-7022 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. 2004N-0565]
Agency Information Collection Activities; Submission for Office ofManagment and Budget Review; Comment Request; State Petitions for ExemptionFrom Preemption
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: Fumie Yokota, 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 44U.S.C. 3507, FDA has submitted the following proposed collection ofinformation to OMB for review and clearance.
State Petitions for Exemption From Preemption-21 CFR 100.1(d)(OMB Control Number 0910-0277)-Extension
Under section 403A(b) of the Federal Food, Drug, and Cosmetic Act (theact) (21 U.S.C. 343-1(b)), States may petition FDA for exemption fromFederal preemption of State food labeling and standard-of-identityrequirements. Section 100.1(d) (21 CFR 100.1(d)) sets forth the informationa State is required to submit in such a petition. The information requiredunder § 100.1(d) enables FDA to determine whether the State foodlabeling or standard-of-identity requirement satisfies the criteria ofsection 403A(b) of the act for granting exemption from Federalpreemption.
In the Federal Register of January 13, 2005 (70 FR 2412),FDA published a 60-day notice requesting public comment on the informationcollection provisions. One comment was received. The comment expressesconcern that it is unnecessary for FDA to maintain a "program"whereby States may petition the FDA to request exemption from preemptionbecause States are not asking for exemptions. The comment asserts that the"program" wastes taxpayer dollars and suggests that FDA abolishit.
Under section 403A(b) of the act, States may petition FDA for exemptionfrom Federal preemption of State food labeling and standard-of-identityrequirements. FDA's regulations at § 100.1(d), the subjectmatter of this information collection, set forth the information a State isrequired to submit in such a petition. Section 100.1(d) implements astatutory information collection requirement. Therefore, FDA cannot abolishthe regulations unless the statute is changed.
FDA estimates the burden of the collection of information asfollows:
| 21 CFR Section | No. of Respondents | Annual Frequency per Response | Total Annual Responses | Hours per Response | Total Hours |
|---|---|---|---|---|---|
| 100.1(d) | 1 | 1 | 1 | 40 | 40 |
| 1 There are no capital costs or operating and maintenancecosts associated with this collection of information. | |||||
The reporting burden for § 100.1(d) is insignificant becausepetitions for exemption from preemption are seldom submitted by States. Inthe last 3 years, FDA has not received any new petitions; therefore, theagency estimates that one or fewer petitions will be submitted annually.Because § 100.1(d) implements a statutory information collectionrequirement, only the additional burden attributable to the regulation hasbeen included in the estimate. Although FDA believes that the burden willbe insignificant, the agency believes these information collectionprovisions should be extended to provide for the potential future need of aState or local government to petition for an exemption from preemptionunder the provisions of section 403(A) of the act.
Dated: April 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7022 Filed 4-7-05; 8:45 am]
BILLING CODE 4160-01-S