Source: https://www.federalregister.gov/documents/2013/12/27/2013-30996/agency-information-collection-activities-submission-for-office-of-management-and-budget-review
Timestamp: 2018-03-19 00:15:32
Document Index: 682181979

Matched Legal Cases: ['§\u20091', '§\u20091', '§\u20091', '§\u20091', '§\u20091', '§\u20091', '§\u20091']

78971-78973 (3 pages)
https://www.federalregister.gov/d/2013-30996 https://www.federalregister.gov/d/2013-30996
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 0910-0520. Also include the FDA docket number found in brackets in the heading of this document.
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002—21 CFR 1.278 to 1.285 (OMB Control Number 0910-0520)—Revision.
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) added section 801(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381(m)), which requires that we receive prior notice for food, including food for animals, that is imported or offered for import into the United States. Sections 1.278 to 1.282 of our regulations (21 CFR 1.278 to 1.282) set forth the requirements for submitting prior notice; §§ 1.283(d) and 1.285(j) (21 CFR 1.283(d) and 1.285(j)) set forth the procedure for requesting our review after we have refused admission of an article of food under section 801(m)(1) of the FD&C Act or placed an article of food under hold under section 801(l) of the FD&C Act; and § 1.285(i) (21 CFR 1.285(i)) sets forth the procedure for post-hold submissions.
Section 304 of the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) amended section 801(m) of the FD&C Act to require a person submitting prior notice of imported food, including food for animals, to report, in addition to other information already required, “any country to which the article has been refused entry.” In the Federal Register of May 5, 2011 (76 FR 25542), we issued an interim final rule (IFR) entitled “Information Required in Prior Notice of Imported Food” (2011 IFR) that implemented section 304 of FSMA and requested public comments. OMB approved the collection of information requirements of the 2011 IFR under OMB control number 0910-0683. On May 30, 2013 (78 FR 32359), we published a final rule that adopts, without change, the regulatory requirements established in the 2011 IFR, specifically that a person submitting prior notice of imported food, including food for animals, must report the name of any country that has refused entry of that product. In this request for extension of OMB approval under the PRA, we are combining the burden hours associated with OMB control number 0910-0683 (collection entitled “Information Required in Prior Notice of Imported Food”) with the burden hours approved under OMB control number 0910-0520 (collection entitled “Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002”).
Much of the information collected for prior notice is identical to the information collected for our importer's entry notice, which has been approved under OMB control number 0910-0046. The information in an importer's entry notice is collected electronically via CBP's ABI/ACS at the same time the respondent files an entry for import with CBP. To avoid double-counting the burden hours already counted in the importer's entry notice information collection, the burden hour analysis in Start Printed Page 78972table 1 of this document reflects our estimate of the reduced burden for prior notice submitted through ABI/ACS in the column labeled “Hours per Response.”
In addition to submitting a prior notice, a submitter should cancel a prior notice and must resubmit the information to us if information changes after we have confirmed a prior notice submission for review (e.g., if the identity of the manufacturer changes) (§ 1.282). However, changes in the estimated quantity, anticipated arrival information, or planned shipment information do not require resubmission of prior notice after we have confirmed a prior notice submission for review (§ 1.282(a)(1)(i) to 1.282(a)(1)(iii)). In the event that we refuse admission to an article of food under section 801(m)(1) or we place it under hold under section 801(l) of the (FD&C Act), §§ 1.283(d) and 1.285(j) set forth the procedure for requesting our review and the information required in a request for review. In the event that we place an article of food under hold under section 801(l) of the (FD&C Act), § 1.285(i) sets forth the procedure for, and the information to be included in, a post-hold submission.
In the Federal Register of November 1, 2013 (78 FR 65670) FDA published a 60-day notice requesting public comment on the proposed collection of information; no comments were received.
1.280-1.281 None 15,000 608 9,120,000 0.167 1,523,040 2
1.280-1.281 FDA 3540 3 26,667 58 1,546,686 0.384 593,927
1.282 FDA 3540 4,098 1 4,098 0.25 1,025
1.282, 1.283(a)(5) FDA 3540 33,096 1 33,096 0.25 8,274
As previously discussed, on May 30, 2013, we published a final rule that adopts, without change, the regulatory requirements established in the 2011 IFR, specifically that a person submitting prior notice of imported food, including food for animals, must report the name of any country that has refused entry of that product. We estimate that it would take on average about one additional minute (0.016 hours) per entry for each respondent to submit prior notice with this additional piece of information. Accordingly, we have increased our estimate of the hours per response for prior notices received through ABI/ACS from 9 minutes, or 0.15 hours, per notice, to 10 minutes, or 0.167 hours, per notice. We have also increased our estimate of the hours per response for prior notices received through PNSI from 22 minutes, or 0.366 hours (rounded to 0.37 hours), per notice, to 23 minutes, or 0.384 hours, per notice.
We received 8,570,504 prior notices through ABI/ACS during 2010; 9,054,187 during 2011; and 9,716,147 during 2012. Based on this experience, we estimate that approximately 15,000 users of ABI/ACS will submit an average of 608 prior notices annually, for a total of 9,120,000 prior notices received annually through ABI/ACS. FDA estimates the reporting burden for a prior notice submitted through ABI/Start Printed Page 78973ACS to be 10 minutes, or 0.167 hours, per notice, for a total burden of 1,523,040 hours. This estimate takes into consideration the burden hours already counted in the information collection approval for our importer's entry notice, as previously discussed in this document.
We have not received any requests for review under §§ 1.283(d) or 1.285(j) in the last 3 years (2010, 2011, and 2012); therefore, we estimate that one or fewer requests for review will be submitted annually. We estimate that it will take a requestor about 8 hours to prepare the factual and legal information necessary to prepare a request for review. Thus, we have estimated a total reporting burden of 8 hours.