Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions

Forms and Documents

Document Name	Status
0233 Patent term restoration SSA 2020 EXT.pdf Supporting Statement A	2020-04-27

IC Document Collections

IC ID	Document Title	Status
5829	Revision of Regulatory Review Period Determinations	Modified
210409	Due diligence hearings	Unchanged
210408	Due diligence petitions	Unchanged

ICR Details

OMB Control No: 0910-0233	ICR Reference No: 202004-0910-006
Status: Active	Previous ICR Reference No: 201704-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/29/2020
	Date Received in OIRA: 04/27/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2023	36 Months From Approved	06/30/2020
Responses	18	0	7
Time Burden (Hours)	594	0	560
Cost Burden (Dollars)	0	0	0

---

Abstract: This information collection supports regulations in 21 CFR part 60 pertaining to patent term restoration and the submission of requests for revision of the regulatory review period under 21 CFR 60.25; due diligence petitions under 21 CFR 60.30; and requests for hearings under 21 CFR 60.40.

---

Authorizing Statute(s): US Code: 35 USC 156 Name of Law: Generic Animal Drug and Patent Term Restoration Act of 1988
   US Code: 21 USC 355(j) Name of Law: Drug Price Competition and Patent Term Restoration Act of 1984
  

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:
	84 FR 43606	08/21/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 3934	01/23/2020
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Revision of Regulatory Review Period Determinations
Due diligence petitions
Due diligence hearings

---

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	18	7	0	0	11	0
Annual Time Burden (Hours)	594	560	0	0	34	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

---

Annual Cost to Federal Government: $0

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.     Yes

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? Uncollected

---

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: 04/27/2020

---