Applications for FDA Approval to Market a New Drug: Patient Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That...

Forms and Documents

Document	Type	Status	Availability
Form 3542 Form FDA 3542	Form	Modified	Repair queued
Form 35421 Form FDA 3542a	Form	Modified	Repair queued
SUPPORTING STATEMENT 0513 FINAL 9-16-13.doc	Supporting Statement A	Uploaded 2013-09-16	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
6229	Form FDA 3542	Form	Modified
179904	Form FDA 3542a	Form	Modified

ICR Details

OMB Control No: 0910-0513	ICR Reference No: 201309-0910-011
Status: Historical Active	Previous ICR Reference No: 201007-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: 20536
Title: Applications for FDA Approval to Market a New Drug: Patient Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That...
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: 10/23/2013
	Date Received in OIRA: 09/20/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2016	36 Months From Approved	10/31/2013
Responses	1,075	0	1,006
Time Burden (Hours)	13,820	0	14,120
Cost Burden (Dollars)	0	0	0

---

Abstract: Section 314.50(h) requires that an NDA, an amendment, or a supplement contain patent information described under Section 314.53. Section 314.53 requires that an pplicant submitting an NDA, an amendment, or a supplement submit on Forms 3542 and 3542a the required patent information. If a patent is issued after the application is filed with FDA but before the application is approved, the applicant must submit the reuqired patent information on Form 3542a as an amendment to the application, within 30 days of the date of issuance of the patent. Within 30 days after the date of approval of an application, the applicant must submit Form 3542 for each patent that claims the drug substance (active ingredient), drug product (formulation and composition), or approved method of use for listing in the Orange Book. In addition, for patents issued after the date of approval of an application, Form 3542 must be submitted within 30 days of the date of issuance of the patent.

---

Authorizing Statute(s): US Code: 21 USC 505(c)(2) Name of Law: The Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 355(b)1 Name of Law: THe Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 355(c)(2) Name of Law: THe Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 505(b)(1) Name of Law: The Federal Food, Drug, and Cosmetic Act
  

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 36193	06/17/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 57164	09/17/2013
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Form FDA 3542	3542	Patent Information Submitted Upon and After Approval of an NDA or Supplement
Form FDA 3542a	35421	Patent Information Submitted With the Filing of an NDA, Amendment, or Supplement

---

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	1,075	1,006	0	0	69	0
Annual Time Burden (Hours)	13,820	14,120	0	0	-300	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 estimated burden hours for this information collection has decreased from 14,120 hours to 13,830 hours. As described in #12 of the Supporting Statement, this decrease is the result of new data and projections on the number of forms we have received and will receive.

---

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: 09/20/2013

---