Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds

Forms and Documents

Document Name	Status
PRACRESPCM.doc Supplementary Document	2006-09-18
PRACRESP ss06.doc Supporting Statement A	2006-09-18

IC Document Collections

IC ID	Document Title	Status
6129	Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds Instruction	Modified

ICR Details

OMB Control No: 0910-0445	ICR Reference No: 200612-0910-003
Status: Historical Active	Previous ICR Reference No: 200307-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds
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: 01/29/2007
	Date Received in OIRA: 12/13/2006
Terms of Clearance: FDA will provide the PRA-mandated burden notice on the guidance document.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2010	36 Months From Approved	01/31/2007
Responses	180	0	164
Time Burden (Hours)	51,120	0	46,576
Cost Burden (Dollars)	0	0	0

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Abstract: Guidance to assist sponsors in submitting responses to clinical holds so that they may be identified as complete responses and the agency can track the time to respond.

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Authorizing Statute(s): PL: Pub.L. 105 - 115 117 Name of Law: FDAMA
  

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 30142	05/25/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 57972	10/02/2006
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds

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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	180	164	0	16	0	0
Annual Time Burden (Hours)	51,120	46,576	0	4,544	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: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: The change in burden estimates is based on more recent data reflecting the number of receipts.

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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: 12/04/2006

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