Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT 0646 FINAL 9-9-13.doc Supporting Statement A	2013-09-09

IC Document Collections

IC ID	Document Title	Status
190230	Submission of a copy of that portion of each annual report containing authorized generic drug information	Modified
190229	Submission of authorized generic drug information on first marketed generics in an annual report	Modified
190228	Submission of authorized generic drug information in each annual report	Modified

ICR Details

OMB Control No: 0910-0646	ICR Reference No: 201309-0910-002
Status: Historical Active	Previous ICR Reference No: 201108-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: 20461
Title: Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs
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: 05/23/2014
	Date Received in OIRA: 09/12/2013
Terms of Clearance: This collection is approved for 1 year to give FDA time to complete migration of this collection into Form 2252 or another viable alternative that eliminates duplication. See prior terms of clearance.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2015	36 Months From Approved	05/31/2014
Responses	1,000	0	1,200
Time Burden (Hours)	290	0	520
Cost Burden (Dollars)	0	0	0

---

Abstract: The New Drug Application holders are required to notify the Agency when an authorized generic drug is marketed by clearly including this information in annual reports in an easily accessible place and by sending a copy of the relevant portion of the annual reports to a central office.

---

Authorizing Statute(s): None

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:
	78 FR 27404	05/10/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 54898	09/06/2013
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
Submission of authorized generic drug information in each annual report
Submission of authorized generic drug information on first marketed generics in an annual report
Submission of a copy of that portion of each annual report containing authorized generic drug information

---

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	1,000	1,200	0	0	-200	0
Annual Time Burden (Hours)	290	520	0	0	-230	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: The reduction in burden hours from 520 to 290 is the result of more recent data on the number of submissions.

---

Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 09/12/2013

---