Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by November 21, 2014.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to firstname.lastname@example.org. All comments should be identified with the OMB control number 0910-0277. Also include the FDA docket number found in brackets in the heading of this document.
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FOR FURTHER INFORMATION CONTACT:
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd.; COLE-14526, Silver Spring, MD 20993-0002 PRAStaff@fda.hhs.gov.
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In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information 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 (the FD&C Act) (21 U.S.C. 343-1(b)), states may petition FDA for exemption from Federal preemption of state food labeling and standard of identity requirements. Section 100.1(d) (21 CFR 100.1(d)) sets forth the information a Start Printed Page 63129state is required to submit in such a petition. The information required under § 100.1(d) enables FDA to determine whether the state food labeling or standard of identity requirement satisfies the criteria of section 403A(b) of the FD&C Act for granting exemption from Federal preemption.
In the Federal Register of August 7, 2014 (79 FR 46269), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
We estimate the annual burden of this collection of information as follows:
Table 1—Estimated Annual Reporting Burden 1
|21 CFR 100.1(d)||Number of respondents||Number of responses per
respondent||Total annual responses||Avg. burden per response||Total hours|
|Form of petition||1||1||1||40||40|
|1 There are no capital costs or operating and maintenance costs associated with this collection of information.|
The reporting burden for § 100.1(d) is minimal because petitions for exemption from preemption are seldom submitted by states. In the last 3 years, we have received one new petition for exemption from preemption; therefore, we estimate that one or fewer petitions will be submitted annually.
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Dated: October 16, 2014.
Assistant Commissioner for Policy.
[FR Doc. 2014-25106 Filed 10-21-14; 8:45 am]
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