2015-03005. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Food and Drug Administration Regulated Products: Export Certificates; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; correction.

SUMMARY:

The Food and Drug Administration is correcting a notice entitled “Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Food and Drug Administration Regulated Products: Export Certificates ” that appeared in the Federal Register of February 6, 2015 (80 FR 6728). The document announced 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. The document was published with three errors. This document corrects those errors.

FOR FURTHER INFORMATION CONTACT:

FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [e-mail].

SUPPLEMENTARY INFORMATION:

In the Federal Register of Friday, February 6, 2015, in FR Doc. 2015-02348, the following corrections are made:

1. On page 6728, in the third column, under the heading Export of Food and Drug Administration Regulated Products: Export Certificates—(OMB Control Number 0910-0498)—Extension, the following sentence is added at the end of the first paragraph: “In January 2011, section 801(e)(4)(A) was amended by the Food Safety Modernization Act (Pub. L. 111-353) to provide authorization for export certification fees for food and animal feed.”

2. On page 6728, in the third column, under the heading Export of Food and Drug Administration Regulated Products: Export Certificates—(OMB Control Number 0910-0498)—Extension, in the second paragraph, the first sentence is revised to read as follows: “This section of the FD&C Act authorizes FDA to issue export certificates for regulated food, animal feed, pharmaceuticals, biologics, and devices that are legally marketed in the United States, as well as for these same products that are not legally marketed but are acceptable to the importing country, as specified in sections 801(e) and 802 of the FD&C Act.”

3. On page 6729, Table 2 is corrected as follows:

Table 2—Estimated Annual Reporting Burden ¹

FDA center	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
Center for Biologics Evaluation and Research	2,114	1	2,114	1	2,114
Center for Devices and Radiological Health	10,528	1	10,528	2	21,056
Center for Veterinary Medicine	1,848	1	1,848	1	1,848
Total					25,018
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: February 9, 2015.

Leslie Kux,

Associate Commissioner for Policy.