Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans

Forms and Documents

Document Name	Status
0672 Supporting Statement A 2016.pdf Supporting Statement A	2016-10-24

IC Document Collections

IC ID	Document Title	Status
194533	312.32(c)(1)(iv); IND Safety Reports	Modified
194532	312.32(c)(1)(ii) and (c)(1)(iii); IND Safety Reports	Modified
194531	320.31(d); Bioavailability and Bioequivalence Safety Reports	Modified

ICR Details

OMB Control No: 0910-0672	ICR Reference No: 201610-0910-008
Status: Historical Active	Previous ICR Reference No: 201311-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
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: 01/23/2017
	Date Received in OIRA: 10/24/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2020	36 Months From Approved	01/31/2017
Responses	1,361	0	810
Time Burden (Hours)	16,724	0	10,120
Cost Burden (Dollars)	0	0	1,950

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Abstract: The information collection supports agency rulemaking. Burden reflects that otherwise captured under OMB Control Nos. 0910-0014, "Investigational New Drug Regulations," and 0910-0291, "MedWatch: FDA’s Medical Products Reporting Program." FDA will incorporate the burden under the instant collection into these collections accordingly.

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Authorizing Statute(s): US Code: 21 USC 321, 331, 351, 352, 353 et al. Name of Law: FD&C Act; Investigational New Drug Application
   US Code: 21 USC 321, 351, 352, 355, 371 Name of Law: FD&C At; Bioavailability and Bioequivalence Requirements
  

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:
	81 FR 14860	03/18/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 73115	10/24/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
312.32(c)(1)(ii) and (c)(1)(iii); IND Safety Reports
320.31(d); Bioavailability and Bioequivalence Safety Reports
312.32(c)(1)(iv); IND Safety Reports

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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	1,361	810	0	0	551	0
Annual Time Burden (Hours)	16,724	10,120	0	0	6,604	0
Annual Cost Burden (Dollars)	0	1,950	0	0	-1,950	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: Fluctuations in burden explained in Q15 of the agency supporting statement.

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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]? 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

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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: 10/24/2016

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