Right to Try Act: Reporting Requirements

ICR 202007-0910-015

OMB: 0910-0893

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2020-08-02
Supplementary Document
2020-08-02
Supporting Statement A
2020-08-02
IC Document Collections
IC ID
Document
Title
Status
242949
New
ICR Details
0910-0893 202007-0910-015
Historical Inactive
HHS/FDA OC
Right to Try Act: Reporting Requirements
New collection (Request for a new OMB Control Number)   No
Regular
Comment filed on proposed rule 09/08/2020
Retrieve Notice of Action (NOA) 08/03/2020
In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.
  Inventory as of this Action Requested Previously Approved
36 Months From Approved
0 0 0
0 0 0
0 0 0

This ICR supports our proposed regulation implementing reporting requirements of the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Right to Try Act). The requirements would establish deadlines, frequency, and content of submissions for manufacturers who provide an eligible investigational drug for use by patients who meet certain criteria as set forth under the Right to Try Act.

PL: Pub.L. 115 - 176 2 Name of Law: Right to Try Act
  
PL: Pub.L. 115 - 176 2 Name of Law: Right to Try Act of 2017

0910-AI36 Proposed rulemaking 85 FR 44803 07/24/2020

No

1
IC Title Form No. Form Name
Annual summaries

No
No
This is a new information collection to implement new statutory requirements.

$284,299
No
    Yes
    No
No
No
No
No
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  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.
08/03/2020


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