Source: https://www.federalregister.gov/articles/2012/03/20/2012-6691/agency-information-collection-activities-proposed-collection-comment-request-guidance-for-industry
Timestamp: 2015-04-26 19:26:55
Document Index: 264757124

Matched Legal Cases: ['§ 312', '§ 312', '§ 312', '§ 312', '§ 312', '§ 312', '§ 312', '§ 312', '§ 312']

Federal Register | Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products
Dates: Submit either electronic or written comments on the collection of information by May 21, 2012.
-16237 (3 pages)
Document Number: 2012-6691
Shorter URL: https://federalregister.gov/a/2012-6691 Regulations.gov Docket Info
Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Formal Meetings with Sponsors and Applicants for Prescription Drug User Fee Act (PDUFA) Products
Guidance for Industry on Formal Meetings With Sponsors and Applicants for PDUFA Products—(OMB Control Number 0910-0429)—Extension Back to Top
This information collection approval request is for FDA guidance on the procedures for formal meetings between FDA and sponsors or applicants regarding the development and review of PDUFA products. The guidance describes procedures for requesting, scheduling, conducting, and documenting such formal meetings. The guidance provides information on how the Agency will interpret and apply section 119(a) of the Food and Drug Administration Modernization Act of 1997 (FDAMA), specific PDUFA goals for the management of meetings associated with the review of human drug applications for PDUFA products, and provisions of existing regulations describing certain meetings (§§ 312.47 and 312.82 (21 CFR 312.47 and 312.82)).
The guidance describes two collections of information: The submission of a meeting request containing certain information and the submission of an information package in advance of the formal meeting. Agency regulations at §§ 312.47(b)(1)(ii), (b)(1)(iv), and (b)(2) describe information that should be submitted in support of a request for an End-of-Phase 2 meeting and a Pre-NDA meeting. The information collection provisions of § 312.47 have been approved by OMB (OMB control number 0910-0014). However, the guidance provides additional recommendations for submitting information to FDA in support of a meeting request. As a result, FDA is submitting additional estimates for OMB approval.
Under the guidance, a sponsor or applicant interested in meeting with the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) should submit a meeting request to the appropriate FDA component as an amendment to the underlying application. FDA regulations (§§ 312.23, 314.50, and 601.2 (21 CFR 312.23, 314.50, and 601.2)) state that information provided to the Agency as part of an Investigational New Drug Application (IND), New Drug Application (NDA), or Biological License Application (BLA) must be submitted with an appropriate cover form. Form FDA 1571 must accompany submissions under INDs and Form FDA 356h must accompany submissions under NDAs and BLAs. Both forms have valid OMB control numbers as follows: FDA Form 1571—OMB control number 0910-0014 and FDA Form 356h—OMB control number 0910-0338.
In the guidance document, CDER and CBER ask that a request for a formal meeting be submitted as an amendment to the application for the underlying product under the requirements of §§ 312.23, 314.50, and 601.2; therefore, requests should be submitted to the Agency with the appropriate form attached, either Form FDA 1571 or Form FDA 356h. The Agency recommends that a request be submitted in this manner for two reasons: (1) To ensure that each request is kept in the administrative file with the entire underlying application and (2) to ensure that pertinent information about the request is entered into the appropriate tracking databases. Use of the information in the Agency's tracking databases enables the Agency to monitor progress on the activities attendant to scheduling and holding a formal meeting and to ensure that appropriate steps will be taken in a timely manner.
The collection of information described in the guidance reflects the current and past practice of sponsors and applicants to submit meeting requests as amendments to INDs, NDAs, and BLAs and to submit background information prior to a scheduled meeting. Agency regulations currently permit such requests and recommend the submission of an information package before an End-of-Phase 2 meeting (§§ 312.47(b)(1)(ii) and (b)(1)(iv)) and a Pre-NDA meeting (§ 312.47(b)(2)). 1. Description of Respondents: A sponsor or applicant for a drug or biological product who requests a formal meeting with the Agency regarding the development and review of a PDUFA product.
As stated earlier, the guidance provides information on how the Agency will interpret and apply section 119(a) of FDAMA, specific PDUFA goals for the management of meetings associated with the review of human drug applications for PDUFA products, and provisions of existing regulations describing certain meetings (§§ 312.47 and 312.82). The information collection provisions in § 312.47 concerning End-of-Phase 2 meetings and Pre-NDA meetings have been approved by OMB (OMB control number 0910-0014). However, the guidance provides additional recommendations for submitting information to FDA in support of a meeting request. As a result, FDA is submitting for OMB approval these additional estimates.