Orphan Drugs

ICR 202011-0910-012

OMB: 0910-0167

Federal Form Document

Forms and Documents
ICR Details
0910-0167 202011-0910-012
Received in OIRA 201711-0910-007
HHS/FDA OC
Orphan Drugs
Revision of a currently approved collection   No
Regular 12/29/2020
  Requested Previously Approved
36 Months From Approved 01/31/2021
4,577 2,144
123,673 106,407
0 0

This information is required in the implementation and administration of the Orphan Drug Act, 21 U.S.C., Sections 526-528. The information is necessary to show that applicants qualify and continue to qualify for the incentives and assistance provided by the statute and regulations.

US Code: 21 USC 360aa Name of Law: FFDCA
   US Code: 21 USC 360bb Name of Law: FFDCA
   US Code: 21 USC 360cc Name of Law: FFDCA
   US Code: 21 USC 360dd Name of Law: FFDCA
  
None

Not associated with rulemaking

  85 FR 62306 10/02/2020
85 FR 83971 12/23/2020
No

  Total Request 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 4,577 2,144 0 4,576 -2,143 0
Annual Time Burden (Hours) 123,673 106,407 0 123,623 -106,357 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
The total number of requests for orphan designation have increased as a result of increased interest by the public and pharmaceutical industry in developing products for people with rare diseases and conditions. The burden was adjusted to reflect this increase. Since there is an increase of applications, sponsors who request a designation from only the FDA have the option of submitting the FDA Orphan Drug Designation Request Form (FDA Form 4035). The estimated annual hourly burden, formerly estimated as 106,407 hours, has increased by 8,250 hours to a total estimated annual hourly burden of 114,657 hours. We are consolidating into this request for approval 0910-0787, “Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products Development” which represents an additional increase in total burden hours of 9,016 hours. Therefore, the increase in total burden hours is 17,266. For the purpose of ease of entry in ROCIS the previously entered eight ICs was reduced to one IC.

$2,750,000
No
    No
    No
No
No
No
No
Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@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.
12/29/2020


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