Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
This script is used to control the display of information in this page.
Display additional information by clicking on the following:
All
Brief and OIRA conclusion
Abstract/Justification
Legal Statutes
Rulemaking
FR Notices/Comments
IC List
Burden
Misc.
Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0167
ICR Reference No:
202011-0910-012
Status:
Historical Active
Previous ICR Reference No:
201711-0910-007
Agency/Subagency:
HHS/FDA
Agency Tracking No:
OC
Title:
Orphan Drugs
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
02/05/2021
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/29/2020
Terms of Clearance:
Approved with the understanding that 0910-0787 will then be discontinued.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
02/29/2024
36 Months From Approved
02/28/2021
Responses
4,577
0
2,144
Time Burden (Hours)
123,673
0
106,407
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
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
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
85 FR 62306
10/02/2020
30-day Notice:
Federal Register Citation:
Citation Date:
85 FR 83971
12/23/2020
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Annual reports of holder of orphan drug designation
Changes in ownership of orphan drug designation
Common European Medicines Agency/Food and Drug Administration Application Form
Form 3671, Form 4035
Common EMEA/FDA Application for Orphan Medicinal Product Designation
,
FDA Application for Orphan Medicinal Product Designation
Deficiency letters and granting orphan-drug designation
Insufficient quantities of orphan drugs
Orphan Drug Designation: requests content and format; notifications of changes; deficiency letters; annual reports; assurance of sufficient quantities; meeting requests
FDA 4035
FDA Orphan Drug Designation Request Form
Orphan Drug: Content and format of a request for designation; verification of status; amendment to designation
Permanent resident agent for foreign sponsor
ICR Summary of Burden
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
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
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
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.
Annual Cost to Federal Government:
$2,750,000
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
12/29/2020
An official website of the United States government
The .gov means it's official.
The site is secure.
