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

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 3542a PATENT INFORMATION SUBMITTED UPON AND	Form	Modified	Available
Form 3542 PATENT INFORMATION SUBMITTED UPON AND	Form	New	Available
FDA-3542a.doc	Supplementary Document	Uploaded 2007-04-18	Available
FDA-3542.doc	Supplementary Document	Uploaded 2007-04-18	Available
pra0513patentforms SS.doc42007.doc	Supporting Statement A	Uploaded 2007-04-18	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
6229	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...	Form	Modified	PATENT INFORMATION SUBMITTED UPON AND
179904	Applications for FDA Approval to Market a New Drug: Patent Listing... 30-month Stays	Form	New	PATENT INFORMATION SUBMITTED UPON AND

ICR Details

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
Retrieve Notice of Action (NOA)	Date Received in OIRA: 04/30/2007
Terms of Clearance:

table that charts list comparision

	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

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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).

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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

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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

table that charts list of burden

IC Title	Form No.	Form Name
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...	3542a	PATENT INFORMATION SUBMITTED UPON AND
Applications for FDA Approval to Market a New Drug: Patent Listing... 30-month Stays	3542	PATENT INFORMATION SUBMITTED UPON AND

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ICR Summary of Burden

table that charts list 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	673	481	0	192	0	0
Annual Time Burden (Hours)	8,840	499,805	0	-490,965	0	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: 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.

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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

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Common Form ICR:  No

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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: 04/30/2007

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