Orphan Drug Regulations

ICR 201110-0910-007

OMB: 0910-0702

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2011-10-18
ICR Details
0910-0702 201110-0910-007
Historical Inactive
HHS/FDA
Orphan Drug Regulations
New collection (Request for a new OMB Control Number)   No
Regular
Comment filed on proposed rule 02/06/2012
Retrieve Notice of Action (NOA) 10/20/2011
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

The Food and Drug Administration (FDA) is proposing to amend the 1992 Orphan Drug Regulations, 21 CFR Part 316 (Attachment A). The 1992 regulations were issued to implement sections 525 through 528 (Attachment B) of the Orphan Drug Act Amendments to the Food, Drug, and Cosmetic Act. The 1992 regulations specify the procedures for sponsors of orphan drugs to use in obtaining the incentives provided for in the Act and set forth the procedures that FDA will use in administering the Act.

US Code: 21 USC 526(c) Name of Law: FFDCA
  
None

0910-AG72 Proposed rulemaking 76 FR 64868 10/19/2011

No

2
IC Title Form No. Form Name
Content and format of a request for orphan-drug designation
Deficiency letters and granting orphan-drug designation

Yes
Changing Regulations
No
This is a new information collection.

$650
No
No
No
No
No
Uncollected
Jonnalynn Capezzuto 3018274659

  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.
10/20/2011


© 2024 OMB.report | Privacy Policy