Investigational New Drug Regulations

Forms and Documents

Document	Type	Status	Availability
Form Form FDA 1571 CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers	Form	Unchanged	Available
0014 Non sub Change July 2019 to include 0672 burden.pdf	Justification for No Material/Nonsubstantive Change	Uploaded 2019-07-25	Available
0014 IND Regs SSA 2019 Ext.pdf	Supporting Statement A	Uploaded 2019-02-27	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
5669	CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers	Form	Unchanged
215564	CBER: IND Required Recordkeeping		Unchanged
189340	CDER: IND Required Recordkeeping		Unchanged
189333	CDER: 312 Subpart I - Expanded Access to Investigational Drugs for Treatment Use; including emergency use of IND		Unchanged
189332	CDER: 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical studies		Unchanged
189331	CDER: 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications		Unchanged
189330	CDER: 312 Subpart C - Administrative Actions; including sponsor requests to FDA		Unchanged
189329	CDER: 312 Subpart B - IND Application; including content and form, safety reports, and annual reports		Unchanged
189328	CDER: 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers		Unchanged
189326	CBER: Part 312 Subpart I - Expanded Access to INDs for Treatment Use; including emergency use of IND		Unchanged
189323	CBER: Part 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical stuides		Unchanged
189320	CBER: Part 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications		Unchanged
189319	CBER: Part 312 Subpart C - Administrative Actions; including sponsor requests to FDA		Unchanged
189313	CBER: Part 312 Subpart B - IND Application; including content and form, safety reports, and annual reports		Unchanged

ICR Details

OMB Control No: 0910-0014	ICR Reference No: 201907-0910-023
Status: Historical Active	Previous ICR Reference No: 201902-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Investigational New Drug Regulations
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/26/2019
	Date Received in OIRA: 07/25/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2022	03/31/2022	03/31/2022
Responses	242,259	0	242,259
Time Burden (Hours)	30,644,761	0	30,644,761
Cost Burden (Dollars)	0	0	0

---

Abstract: This information collection supports FDA regulations regarding investigational new drug applications. The IND requirements provide the means by which FDA can: (a) monitor the safety of ongoing clinical investigations; (b) determine whether the clinical testing of a drug should be authorized; (c) ensure production of reliable data on the metabolism and pharmacological action of the drug in humans; (d) obtain timely information on adverse reactions to the drug; (e) obtain information on side effects associated with increasing doses; (f) obtain information on the drug's effectiveness; (g) ensure the design of well-controlled, scientifically valid studies; and (h) obtain other information pertinent to determining whether clinical testing should be continued and information related to the protection of human subjects.

---

Authorizing Statute(s): US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
  

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 50102	10/04/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 3462	02/12/2019
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 14

IC Title	Form No.	Form Name
CBER: Part 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications
CDER: 312 Subpart B - IND Application; including content and form, safety reports, and annual reports
CDER: 312 Subpart C - Administrative Actions; including sponsor requests to FDA
CBER: Part 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical stuides
CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers	Form FDA 1572, Form FDA 1571	Investigational New Drug Application ,   Statement of Investigator
CBER: Part 312 Subpart B - IND Application; including content and form, safety reports, and annual reports
CBER: Part 312 Subpart C - Administrative Actions; including sponsor requests to FDA
CBER: Part 312 Subpart I - Expanded Access to INDs for Treatment Use; including emergency use of IND
CDER: 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers
CDER: IND Required Recordkeeping
CDER: 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications
CDER: 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical studies
CBER: IND Required Recordkeeping
CDER: 312 Subpart I - Expanded Access to Investigational Drugs for Treatment Use; including emergency use of IND

---

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	242,259	242,259	0	0	0	0
Annual Time Burden (Hours)	30,644,761	30,644,761	0	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: The information collection, therefore, reflects a cumulative increase in burden by 81,332 annual responses and 7,843,950 burden hours attributable to a growing number of investigational new drug applications and associated research.

---

Annual Cost to Federal Government: $146,125,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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

---

Common Form ICR:  No

---

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: 07/25/2019

---