Guidance for Industry, Researchers, Patient Groups, and FDA Staff on Meetings with the Office of Orphan Products Development

ICR 201411-0910-014

OMB: 0910-0787

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0787 201411-0910-014
Historical Active
Guidance for Industry, Researchers, Patient Groups, and FDA Staff on Meetings with the Office of Orphan Products Development
New collection (Request for a new OMB Control Number)   No
Approved without change 05/18/2015
Retrieve Notice of Action (NOA) 03/04/2015
  Inventory as of this Action Requested Previously Approved
05/31/2018 36 Months From Approved
2,279 0 0
8,184 0 0
0 0 0

The collection of information described in the guidance is intended to provide background information in support of consistent procedures to promote well-managed meetings between OOPD and stakeholders. In some cases, these meetings may represent a critical point in the orphan product development process and may even have an impact on the eventual availability of products for patients with rare diseases and conditions. It is therefore important that these meetings be scheduled within a reasonable time, conducted effectively, and documented where appropriate. The draft guidance describes three collections of information: (1) The submission of a meeting request (for informal and formal meeting), (2) the submission of a meeting package (for formal meetings), and (3) the submission of draft meeting minutes (for formal and certain informal meetings.)

US Code: 24 USC 241 Name of Law: null

Not associated with rulemaking

  79 FR 19624 04/09/2014
79 FR 75566 12/18/2014

IC Title Form No. Form Name
Meeting requests (formal and informal); meeting packages; meeting minutes

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 2,279 0 0 2,279 0 0
Annual Time Burden (Hours) 8,184 0 0 8,184 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Miscellaneous Actions
This is a new information collection.

Jonna Capezzuto 301 796-3794 [email protected]


On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

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