Source: https://www.federalregister.gov/documents/2012/03/20/2012-6691/agency-information-collection-activities-proposed-collection-comment-request-guidance-for-industry
Timestamp: 2017-02-23 11:49:04
Document Index: 296784434

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

:: 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
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
Submit either electronic or written comments on the collection of information by May 21, 2012.
77 FR 16235
16235-16237
2012-6691
FDA-2012-N-0247
Guidance for Industry on Formal Meetings With Sponsors and Applicants for PDUFA Products—(OMB Control Number 0910-0429)—Extension
A. Request for a Meeting
B. Information Package
C. Request For a Formal Meeting
D. Information Package
https://www.federalregister.gov/d/2012-6691
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection contained in the guidance for industry on formal meetings with sponsors and applicants for Prescription Drug User Fee Act (PDUFA) products.
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.
Under the guidance, the Agency requests that sponsors and applicants include in meeting requests certain information about the proposed meeting. Such information includes:
The type of meeting being requested;
A list of objectives and expected outcomes from the meeting;
A preliminary proposed agenda;
A draft list of questions to be raised at the meeting;
A list of individuals who will represent the sponsor or applicant at the meeting;
The approximate date that the information package will be sent to the Agency; and
A sponsor or applicant submitting an information package to the Agency in advance of a formal meeting should provide summary information relevant to the product and supplementary information pertaining to any issue raised by the sponsor, applicant, or Agency. The Agency recommends that information packages generally include:
A list of objectives and expected outcomes of the meeting;
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.
2. Burden Estimate: Provided below is an estimate of the annual reporting burden for the submission of meeting requests and information packages under the guidance.
Based on data collected from the review divisions and offices within CDER and CBER, FDA estimates that approximately 975 sponsors and applicants (respondents) request approximately 2,014 formal meetings with CDER annually and approximately 127 respondents request approximately 253 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 756 respondents submitted approximately 1,394 information packages to CDER annually and approximately 112 respondents submitted approximately 203 information packages to CBER annually prior to 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 about 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 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.
Table 1—Estimated Annual Reporting BurdenMeeting requests and information packagesNumber of respondentsNumber of responses per respondentTotal annual responsesAverage burden per responseTotal hoursMeeting RequestsCDER9752.062,0141020,140CBER1271.99253102,530Total22,670Information PackagesCDER7561.841,3941825,092CBER1121.81203183,654Total28,746Grand Total51,416
[FR Doc. 2012-6691 Filed 3-19-12; 8:45 am]