Source: https://www.federalregister.gov/documents/2008/11/13/E8-27008/agency-information-collection-activities-proposed-collection-comment-request-guidance-for-industry
Timestamp: 2017-09-26 04:42:52
Document Index: 86098873

Matched Legal Cases: ['§\u2009312', '§\u2009312', '§\u2009312', '§\u2009312', '§\u2009312', '§\u2009312', '§\u2009312', '§\u2009312']

Submit written or electronic comments on the collection of information by January 12, 2009.
73 FR 67184
Docket No. FDA-2008-N-0556
E8-27008
https://www.federalregister.gov/d/E8-27008 https://www.federalregister.gov/d/E8-27008
This information collection approval request is for an 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 (the Modernization Act), 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 Start Printed Page 67185support of a request for an End-of-Phase 2 meeting and a Pre-New Drug Application meeting. The information collection provisions of § 312.47 have been approved by OMB (OMB Control No. 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), 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 No. 0910-0014) and FDA Form 356h (OMB Control No. 0910-0338).
Under the guidance, the agency requests that sponsors and applicants include in meeting requests certain information about the proposed meeting as follows:
Identifying information about the underlying product,
A list of objectives and expected outcomes of the meeting,
A proposed agenda for the meeting,
A list of specific questions to be addressed at the meeting,
A summary of clinical data that will be discussed (as appropriate),
A summary of preclinical data that will be discussed (as appropriate), and
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)).
Burden Estimate: An estimate of the annual reporting burden for the submission of meeting requests and information packages under the guidance is provided in table 1 of this document.
Based on data collected from the review divisions and offices within CDER and CBER, FDA estimates that approximately 907 sponsors and applicants (respondents) request approximately 2,210 formal meetings with CDER annually and approximately 144 respondents request approximately 287 formal meetings with CBER annually regarding the development and review of a PDUFA product. The hours per response, which is the estimated number of hours that a respondent would spend preparing the information to be submitted with a meeting request in accordance with the guidance, is estimated to be approximately 10 hours. Based on FDA's experience, the agency expects it will take respondents this amount of time to gather and copy brief statements about the product and a description of the purpose and details of the meeting.
Based on data collected from the review divisions and offices within CDER and CBER, FDA estimates that approximately 774 respondents submitted approximately 1,705 information packages to CDER annually and approximately 120 respondents submitted approximately 198 information packages to CBER annually before a formal meeting regarding the development and review of a PDUFA product. The hours per response, which is the estimated number of hours that a respondent would spend preparing the information package in accordance with the guidance, is estimated to be approximately 18 hours. Based on FDA's experience, the agency expects it will take respondents this amount of time to gather and copy brief statements Start Printed Page 67186about the product, a description of the details for the anticipated meeting, and data and information that generally would already have been compiled for submission to the agency.
As stated earlier, the guidance provides information on how the agency will interpret and apply section 119(a) of the Modernization Act, 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 No. 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 these additional estimates for OMB approval.
CDER 907 2.44 2,210 10 22,100
CBER 144 1.99 287 10 2,870
Total 24,970
CDER 774 2.20 1,705 18 30,690
CBER 120 1.65 198 18 3,564
Total 34,254
Grand Total 59,224
[FR Doc. E8-27008 Filed 11-12-08; 8:45 am]