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

ICR 201802-0910-002

OMB: 0910-0787

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2018-03-07
IC Document Collections
ICR Details
0910-0787 201802-0910-002
Active 201411-0910-014
HHS/FDA OC
Guidance for Industry, Researchers, Patient Groups, and FDA Staff on Meetings with the Office of Orphan Products Development
Extension without change of a currently approved collection   No
Regular
Approved without change 05/15/2018
Retrieve Notice of Action (NOA) 03/08/2018
  Inventory as of this Action Requested Previously Approved
05/31/2021 36 Months From Approved 05/31/2018
2,508 0 2,279
9,016 0 8,184
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 The draft guidance describes three collections of information: (1) The submission of a meeting request (for informal and formal meeting), (2) the submission of a meeting package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
  
None

Not associated with rulemaking

  82 FR 54357 11/17/2017
83 FR 8880 03/01/2018
No

1
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 2,508 2,279 0 0 229 0
Annual Time Burden (Hours) 9,016 8,184 0 0 832 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The change in burden hour is a result of an increase in meeting requests over the past 3 years. The estimated annual hourly burden, formerly estimated as 8,184 hours, has increased by 832 hours to a total estimated annual hourly burden of 9,016 hours.

$180,450
No
    No
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [email protected]

  No

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.
03/08/2018


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