Certification to Accompany Drug, Biological Product, and Device Applications or Submissions

Forms and Documents

Document Name	Status
ClinicalTrials govData BankFormFINALDRAFTv 21.pdf Supplementary Document	2007-12-19
FDAAA emergency notice pub 12-12-07 72 FR 70599.pdf Supplementary Document	2007-12-12
FDAAA Title VIII-Public Law 110-85.pdf Supplementary Document	2007-12-12
FDAAA emergency ss 12-12-07.doc Supporting Statement A	2007-12-12

IC Document Collections

IC ID	Document Title	Status
183055	Certification to Accompany Drug, Biological Product, and Device Applications or Submissions Other-Public Law	New
183054	Certification to Accompany Drug, Biological Product, and Device Applications or Submissions Other-Public Law	New

ICR Details

OMB Control No: 0910-0616	ICR Reference No: 200712-0910-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 12/17/2007
OIRA Conclusion Action: Approved with change	Conclusion Date: 12/19/2007
	Date Received in OIRA: 12/13/2007
Terms of Clearance: This information collection request is approved as amended for 6 months pursuant to the emergency provisions of the PRA. Consistent with those provisions, FDA will resubmit the collection for review prior to expiration. FDA will use this abbreviated approval period to work with respondents to ensure that they understand these new requriements and when they are applicable. FDA will also continue to evaluate the comments received with this submission as well as comments received on its 60 day notice to determine if there are additional ways to clarify the form and its instructions. OMB appreciates FDA's efforts in this regard.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2008	6 Months From Approved
Responses	54,782	0	0
Time Burden (Hours)	24,420	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Sponsors of investigational new drug applications (IND) and marketing applications (NDA, BLA, PMA, 510k, HDE) are required, under the Food and Drug Administration Amendments Act of 2007, to certify that all applicable requirements have been met. Sponsors of applicable clinical trials are required to submit information to the publicly-accessible clinical trials data bank, ClinicalTrials.gov.

Emergency Justfication: The emergency processing was requested in order to comply with the provisions of Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Public Law 110-85, which require this certification to be submitted to FDA beginning no later than December 26, 2007. This information will be needed immediately to implement these provisions of FDAAA, and it is essential to the agency's mission of protecting and promoting the public health. Since the statutory deadline for collecting the information is December 26, the lack of a form would result in confusion for the sponsors/applicants as the information necessary for FDA to carry out its future statutory responsibilities would not be obvious without the form. While some sponsors/applicants may submit information, it most likely would not be complete nor provided in a systematic fashion so that it can be more easily retrieved.

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Authorizing Statute(s): PL: Pub.L. 110 - 85 VIII Name of Law: Food and Drug Administration Amendments Act of 2007
  

Citations for New Statutory Requirements: PL: Pub.L. 110 - 85 VIII Name of Law: Food and Drug Administration Amendments Act of 2007

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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

Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
Certification to Accompany Drug, Biological Product, and Device Applications or Submissions

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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	54,782	0	54,782	0	0	0
Annual Time Burden (Hours)	24,420	0	24,420	0	0	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: This is a new collection of information and is necessary to satisfy the statutory requirement P.L. 110-85.

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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: 12/13/2007

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