Source: https://www.federalregister.gov/articles/2013/06/26/2013-15250/draft-guidance-for-industry-on-expedited-programs-for-serious-conditions-drugs-and-biologics
Timestamp: 2016-05-04 08:01:26
Document Index: 20225985

Matched Legal Cases: ['arts 314', 'arts 314', 'art 314', '§ 314', 'art 601', 'art 314', '§ 314', '§ 314']

Federal Register | Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics; Availability
Dates: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 26, 2013. Submit either electronic or written comments concerning the proposed collection of information by August 26, 2013.
-38351 (3 pages)
Document Number: 2013-15250
Shorter URL: https://federalregister.gov/a/2013-15250 Action
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; or the Office of Communication, Outreach, and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Melissa Robb, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6360, Silver Spring MD 20993-0002, 301-796-2500; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6210.
This draft guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR 202.1, parts 314 and 601 (21 CFR parts 314 and 601), and sections 505(a), 506(a)(1), 735, and 736 of the FD Act (21 U.S.C. 355(a), 356(a)(1), 379g, and 379h) have been approved under OMB control numbers 0910-0686, 0910-0001, 0910-0338, 0910-0014, and 0910-0297.
Breakthrough Therapy Designation Request. The draft guidance describes the process for sponsors to request breakthrough therapy designation in an application. Based on information available to FDA, we estimate that approximately 24 sponsors will prepare approximately 1 breakthrough therapy designation submission in accordance with the draft guidance and that the added burden for each submission will be approximately 70 hours to prepare and submit (totaling 1,680 hours).
Promotional Materials for Accelerated Approval Under Part 314. The draft guidance describes section 506(c)(2)(B) of the FD&C Act and FDA's accelerated approval regulations (§§ 314.550 and 601.45). These provisions authorize FDA to require sponsors to submit copies of all promotional materials to the Agency for consideration prior to their dissemination. The regulations provide that copies of all promotional materials including promotional labeling as well as advertisements intended for dissemination or publication within 120 days following marketing approval must be submitted to FDA during the preapproval period. The regulations further provide that after 120 days following marketing approval, unless otherwise informed by the Agency, the applicant must submit promotional materials at least 30 days prior to the intended time of initial dissemination of the labeling or initial publication of the advertisement. Currently, FDA has OMB approval for the submission of copies of all promotional materials under part 601 (OMB control number 0910-0338) but does not have approval for the submission of copies of all promotional materials under part 314.
Based on information from FDA's databases and information available to FDA, we estimate that approximately 20 sponsors will submit promotional materials for accelerated approval 7 times annually in accordance with § 314.550 and that the burden for each submission will be approximately 120 hours (a total of 16,800 hours).
Priority Review Designation Request
Breakthrough Therapy Designation Request
Promotional Materials for Accelerated Approval Under § 314.550