Investigational New Drug Regulations

Forms and Documents

Document Name	Status
0910-0014 - Supporting Statement A.doc Supporting Statement A	2012-04-16

IC Document Collections

IC ID	Document Title	Status
5669	312.2(e) Request for advice on applicability of part 312	Modified
197926	312.320 Submissions related to treatment IND or treatment protocol	New
197925	312.315(c) and 312.305 (b) Submissions related to expanded access and treatment of an individual patient.	New
197924	312.310(d) Emergency use of an investigational new drug	New
189367	312.160(c) Biologics; Shipper records of alternative disposition of unused drugs	Modified
189366	312.160(a)(3) Biologics; Records maintenance: shipment of drugs for investigational use in laboratory research animals or in vitro tests	Modified
189365	312.62(b) Biologics; Investigator recordkeeping of case histories of individuals	Modified
189364	312.62(a) Biologics; Investigator recordkeeping of disposition of drugs	Modified
189363	312.57(a)(b) Biologics; Sponsor recordkeeping	Modified
189362	312.52(a) Biologics; Transfer of obligations to a contract research organization	Modified
189361	312.130(d) Biologics; Request for disclosable information for investigations involving an exception from informed consent	Modified
189360	312.110(b) Request to export an investigational drug	Modified
189359	312.70(a) Biologics; Investigator disqualification - opportunity to respond	Modified
189358	312.64 Investigator Reports to the sponsor	Modified
189357	312.58(a) Biologics; Sponsor submission of records	Modified
189356	312.56(b) and (d) Biologics; Sponsor monitoring of clinical investigations; notification to FDA	Modified
189355	312.55(b) Biologics; Sponsor reports on new observations; e.g. adverse reactions and safe use	Modified
189354	312.54(a) and (b) Biologics; Submissions concerning exception from informed consent under 50.24	Modified
189353	312.53(c) Biologics; Investigator Information	Modified
189352	312.47(b) Biologics; End-of-Phas 2 and Pre-NDA meetings	Modified
189351	312.45(a) and (b) Biologics; Request for or response to inactive status determination	Modified
189350	312.44(c) and (d) Biologics; Response to termination of IND	Modified
189349	312.42(e) Biologics; Request to remove clinical hold	Modified
189348	312.38(b)(c) Biologics; Notification of withdrawal of an IND	Modified
189347	Investigational New Drug Regulations	Removed
189346	Investigational New Drug Regulations	Removed
189345	312.33(a) -(f) and 312.56(c) Biologics; Annual reports and related notifications	Modified
189344	312.32(c)(d) and 312.56(c) Biologics; Safety Reports and Notifications	Modified
189343	312.31(b) Biologics; Information amendments	Modified
189342	312.30(a)-(e) Biologics; Protocol Amendments	Modified
189341	312.23 and 312.120(b)(c)(2)(c)(3). Biologics; Investigational New Drug Submission	Modified
189340	312.8 Biologics; Charging for investigational drugs under an IND	Modified
189339	312.160(c) Shipper records of alternative disposition of unused drugs	Modified
189338	312.60(a)(3)Records of shipment of drugs for investigational use in laboratory research animals or in vitro tests	Modified
189337	312.62(b) Investigator recordkeeping of case histories of individuals	Modified
189336	312.62(a) Investigator recordkeeping of disposition of drugs	Modified
189335	312.57 Sponsor recordkeeping	Modified
189334	312.52(a) Transfer of obligations to a contract research organization	Modified
189333	312.130(d) Request for disclosable information for investigations involving an exception from informed consent	Modified
189332	312.120 Submissions related to foreign clinical studies not conducted under an IND	Modified
189331	312.110(b) Request to export and investigational drug	Modified
189330	312.70(a) Investigator disqualification; opportunity to respond	Modified
189329	312.64 Investigator reports to the sponsor	Modified
189328	312.58(a) Submission of records to FDA	Modified
189327	312.56(b)(c)(d) Sponsor monitoring of investigations;notifications to FDA	Modified
189326	312.55(b) Sponsor reports on new observations, e.g. adverse reactions and safe use	Modified
189325	312.54(a)(b) Submissions concerning exception from informed consent under 50.24	Modified
189324	312.53(c) Investigator Information	Modified
189323	312.47(b) End-of-Phase 2 and Pre-NDA meetings	Modified
189322	312.45(a)(b) Request for or response to inactive status determination	Modified
189321	312.44(c)(d) Response to termination of IND	Modified
189320	312.42(e) Request to remove clinical hold	Modified
189319	312.38(b)(c) Notification of withdrawal of an IND	Modified
189318	312.310(b) and 312.305(b) Submissions related to expanded access and treatment of an individual	Modified
189317	312.8 Charging for investigational drugs under an IND	Modified
189316	312.33 Annual Reports	Modified
189315	312.32(c)-(d) Safety Reports	Modified
189314	312.31(b) Information Amendments	Modified
189313	312.30(a)-(e) Protocol Amendments	Modified
189312	312.23 Investigational New Drug submission	Modified
189311	312.10 Applications for waiver of requirements under part 312	Modified

ICR Details

OMB Control No: 0910-0014	ICR Reference No: 201105-0910-011
Status: Historical Active	Previous ICR Reference No: 200905-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Investigational New Drug Regulations
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 04/16/2012
	Date Received in OIRA: 05/31/2011
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for three years. Following approval of this ICR, FDA will discontinue the following control numbers: 0910-0651 and 0910-0653. In the future, the agency should consider collapsing the ICs into categories (e.g., recordkeeping, reporting) and should provide meaningful titles to each IC in ROCIS to make the information provided to the public clearer. It is not appropriate to use only a provision number as a title for an IC. The agency is also reminded that failure to properly identify and explain the information contained in the ICR can be the basis for an improper submission. Regulatory citations must be correct in both the supporting statement and ROCIS and fully described in the supporting statement.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2015	36 Months From Approved	04/30/2012
Responses	2,685,772	0	2,744,640
Time Burden (Hours)	141,870,849	0	141,492,162
Cost Burden (Dollars)	0	0	0

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Abstract: Information collection from applicants who apply for approval of an investigational new drug application in order to develop a drug for marketing.

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Authorizing Statute(s): US Code: 21 USC 355(i) Name of Law: FFDCA
  

Citations for New Statutory Requirements: US Code: 21 USC 312 Name of Law: FFDCA

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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:
	76 FR 4914	01/27/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 27328	05/11/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 59

IC Title	Form No.	Form Name
312.52(a) Biologics; Transfer of obligations to a contract research organization
312.62(a) Biologics; Investigator recordkeeping of disposition of drugs
312.62(b) Biologics; Investigator recordkeeping of case histories of individuals
312.160(a)(3) Biologics; Records maintenance: shipment of drugs for investigational use in laboratory research animals or in vitro tests
312.57(a)(b) Biologics; Sponsor recordkeeping
312.33 Annual Reports
312.8 Charging for investigational drugs under an IND
312.310(b) and 312.305(b) Submissions related to expanded access and treatment of an individual
312.38(b)(c) Notification of withdrawal of an IND
312.42(e) Request to remove clinical hold
312.44(c)(d) Response to termination of IND
312.45(a)(b) Request for or response to inactive status determination
312.32(c)-(d) Safety Reports
312.53(c) Investigator Information
312.54(a)(b) Submissions concerning exception from informed consent under 50.24
312.55(b) Sponsor reports on new observations, e.g. adverse reactions and safe use
312.160(c) Shipper records of alternative disposition of unused drugs
312.47(b) End-of-Phase 2 and Pre-NDA meetings
312.56(b)(c)(d) Sponsor monitoring of investigations;notifications to FDA
312.58(a) Submission of records to FDA
312.8 Biologics; Charging for investigational drugs under an IND
312.23 and 312.120(b)(c)(2)(c)(3). Biologics; Investigational New Drug Submission
312.30(a)-(e) Biologics; Protocol Amendments
312.31(b) Biologics; Information amendments
312.32(c)(d) and 312.56(c) Biologics; Safety Reports and Notifications
312.33(a) -(f) and 312.56(c) Biologics; Annual reports and related notifications
312.38(b)(c) Biologics; Notification of withdrawal of an IND
312.42(e) Biologics; Request to remove clinical hold
312.44(c) and (d) Biologics; Response to termination of IND
312.45(a) and (b) Biologics; Request for or response to inactive status determination
312.47(b) Biologics; End-of-Phas 2 and Pre-NDA meetings
312.53(c) Biologics; Investigator Information
312.54(a) and (b) Biologics; Submissions concerning exception from informed consent under 50.24
312.55(b) Biologics; Sponsor reports on new observations; e.g. adverse reactions and safe use
312.56(b) and (d) Biologics; Sponsor monitoring of clinical investigations; notification to FDA
312.58(a) Biologics; Sponsor submission of records
312.64 Investigator Reports to the sponsor
312.70(a) Biologics; Investigator disqualification - opportunity to respond
312.110(b) Request to export an investigational drug
312.130(d) Biologics; Request for disclosable information for investigations involving an exception from informed consent
312.160(c) Biologics; Shipper records of alternative disposition of unused drugs
312.310(d) Emergency use of an investigational new drug
312.315(c) and 312.305 (b) Submissions related to expanded access and treatment of an individual patient.
312.320 Submissions related to treatment IND or treatment protocol
312.110(b) Request to export and investigational drug
312.57 Sponsor recordkeeping
312.62(a) Investigator recordkeeping of disposition of drugs
312.62(b) Investigator recordkeeping of case histories of individuals
312.60(a)(3)Records of shipment of drugs for investigational use in laboratory research animals or in vitro tests
312.64 Investigator reports to the sponsor
312.70(a) Investigator disqualification; opportunity to respond
312.130(d) Request for disclosable information for investigations involving an exception from informed consent
312.52(a) Transfer of obligations to a contract research organization
Investigational New Drug Regulations
Investigational New Drug Regulations
312.120 Submissions related to foreign clinical studies not conducted under an IND
312.2(e) Request for advice on applicability of part 312
312.10 Applications for waiver of requirements under part 312
312.23 Investigational New Drug submission
312.30(a)-(e) Protocol Amendments
312.31(b) Information Amendments

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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	2,685,772	2,744,640	0	-41	-58,827	0
Annual Time Burden (Hours)	141,870,849	141,492,162	0	-940	379,627	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: The hour changes for this ICR are the result of burden hours associated with new rulemaking that have been added to this extension. These new burden hours are indicated in the following "21 CFR sections" of Table 1: 312.2(e); 312.8; 312.10; 312.120; 312.310(b) & 312.305(b); 312.310(d); 312.315(c) & 312.305(b); and 312.320.

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Annual Cost to Federal Government: $63,679,000

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: 05/31/2011

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