Source: https://www.federalregister.gov/documents/2014/09/17/2014-22088/agency-information-collection-activities-submission-for-office-of-management-and-budget-review
Timestamp: 2017-08-22 07:31:45
Document Index: 708745860

Matched Legal Cases: ['§\u2009314', '§\u2009314', '§\u2009314', '§\u2009314', '§\u2009314', '§\u2009314', 'arts 10', '§\u2009314']

Fax written comments on the collection of information by October 17, 2014.
79 FR 55801
https://www.federalregister.gov/d/2014-22088 https://www.federalregister.gov/d/2014-22088
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 0910-0001. Also include the FDA docket number found in brackets in the heading of this document.
Section 314.80(i) establishes recordkeeping requirements for reports of postmarketing adverse drug experiences. (The burden hours for Start Printed Page 55802§ 314.80(i) are already approved by OMB under OMB control numbers 0910-0230 and 0910-0291 and are not included in the burden estimates in table 1 of this document.)
Section 314.107(c) requires notice to FDA by the first applicant to submit a substantially complete ANDA containing a certification that a relevant patent is invalid, unenforceable, or will not be infringed of the date of first commercial marketing. (The information collection burden estimate for § 314.107(c) is included in table 1 of this document under the estimates for § 314.50 (a), (b), (c), (d), (e), (f), (g), (i), (j), (k) and (l)).
Section 314.107(e) requires that an applicant submit a copy of the entry of the order or judgment to FDA within 10 working days of a final judgment. (The information collection burden estimate for § 314.107(e) applications is included in table 1 of this document under the estimates for § 314.50 (a), (b), (c), (d), (e), (f), (g), (i), (j), (k) and (l)).
Section 314.151(c) sets forth the requirements for withdrawal of approval of an ANDA and the applicant's opportunity to submit written objections and participate in a limited oral hearing. (The burden hours for § 314.151(c) are included under parts 10 through 16 hearing regulations, in accordance with § 314.201, and are not included in the Start Printed Page 55803burden estimates in table 1 of this document.)
Section 314.550 requires an applicant with a new drug product being considered for accelerated approval to submit copies of all promotional materials to FDA during the preapproval and post-approval periods.
In the Federal Register of March 24, 2014 (79 FR 16003), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received one comment. The comment requested clarification of the duties, responsibilities, and potential liabilities of the person denoted as the “Authorized U.S. Agent” in field 39 of Form FDA 356h. The comment also requested that the formatting for field 39 be revised to clarify, “What exactly it is that the Authorized U.S. Agent is attesting to by its signature.”
FDA response: Neither the form nor the instructions are intended to capture the exact duties, responsibilities, and potential liabilities of the person identified in field 39. Rather, as the instructions indicate, field 39 is intended to capture a countersignature where one is required in accordance with 21 CFR 314.50(a)(5): If the person signing the form in Field 38 does not reside or have a place of business within the United States, the form must be countersigned in Field 39 by an attorney, agent, or other authorized official who resides or maintains a place of business within the United States.Start Printed Page 55804
314.50(a), (b), (c), (d), (e), (f), (g), (i), (j), (k) and (l) [356h] 106 1.42 151 1,921 290,071
314.101(a) 1 1 1 * .50 .50
[FR Doc. 2014-22088 Filed 9-16-14; 8:45 am]