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OMB Control No: 0910-0513	ICR Reference No: 200704-0910-004
Status: Historical Active	Previous ICR Reference No: 200306-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
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: 07/06/2007
	Date Received in OIRA: 04/30/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2010	36 Months From Approved	06/30/2007
Responses	673	0	481
Time Burden (Hours)	8,840	0	499,805
Cost Burden (Dollars)	0	0	0

Abstract: The proposal would amend FDA's patient listing requirements for new drug applications (NDA's). The proposal would clarify the types of patents that must and must not be listed and revise the declaration that NDA applicants must provide regarding their patents to help ensure that NDA applicants list only appropriate patents. The proposal would also revise the regulations regarding the effective date of approval for certain abbreviated new drug applications (ANDA's) and certain applications submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (505(b)(2) applications).

Authorizing Statute(s): US Code: 21 USC 355(b)1 Name of Law: THe Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 505(c)(2) 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:
	71 FR 32099	06/02/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 21266	04/30/2007
Did the Agency receive public comments on this ICR? Yes

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	673	481	192
Annual Time Burden (Hours)	8,840	499,805	-490,965
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Changing Regulations

Short Statement: The information collection burden for section 314.50(h) (citing section 314.53) and Forms 3542 and 3542a will decrease from the estimate we made in the June 2003 final rule for sections 314.50(a) through (f), (h), and (k), and Forms 3542 and 3542a of 498,464 hours to 8,840 hours ((365 annual responses x 20 hours per response = 7,300 hours) + (308 annual responses x 5 hours per response = 1,540 hours) = 8,840 total hours). As stated earlier, certain sections of the June 2003 final rule regarding the application of 30-month stays on approval of certain ANDAs and certain other new drug applications, known as 505(b)(2) applications, submitted under the act, were superseded by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, signed December 8, 2003. The affected sections of the regulations issued in the June 2003 final rule sections 314.52(a)(3) and 314.95(a)(3) (21 CFR 314.52(a)(3) and 21 CFR 314.95(a)(3)) were revoked by the technical amendment to the June 2003 final rule published in the Federal Register of March 10, 2004 (69 FR 11309). Accordingly, FDA's request to extend approval under the PRA for the collection of information contained in the June 2003 final rule is revised to exclude the revoked sections of the regulations, sections 314.52(a)(3) and 314.95(a)(3), and certain sections of the regulations, sections 314.50(i)(1)(i) and 314.94(a)(12), which were included in the estimated annual reporting burden to describe an information collection burden associated with the revoked sections of the regulations.

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

Agency Contact: Saleda Perryman

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