79 FR 204 pgs. 63128-63129 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Petitions for Exemption From Preemption
Type: NOTICEVolume: 79Number: 204Pages: 63128 - 63129
Pages: 63128, 63129Docket number: [Docket No. FDA-2014-N-1104]
FR document: [FR Doc. 2014-25106 Filed 10-21-14; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1104]
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Petitions for Exemption From Preemption
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
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.
DATES:
Fax written comments on the collection of information by November 21, 2014.
ADDRESSES:
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 oira_submission@omb.eop.gov. 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.
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.
SUPPLEMENTARY INFORMATION:
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)
[top] 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
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:
| 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.
Dated: October 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25106 Filed 10-21-14; 8:45 am]
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