Final Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes to be Documented in Annual Reports

Forms and Documents

Document	Type	Status	Availability
SUPPORTING STATEMENT CMC FINAL 9-16-13.doc	Supporting Statement A	Uploaded 2013-11-04	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
209222	Supplements and Annual Reports for Abbreviated New Drug Applications	Other-Guidance	New
209221	Supplements and Annual Reports for New Drug Applications	Other-Guidance	New

ICR Details

OMB Control No: 0910-0758	ICR Reference No: 201311-0910-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: 20836
Title: Final Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes to be Documented in Annual Reports
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/27/2014
	Date Received in OIRA: 11/06/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2017	36 Months From Approved
Responses	2,876	0	0
Time Burden (Hours)	286,150	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: The information collection pertains to the types of CMC postapproval manufacturing changes that FDA has determined will likely have a minimal potential to have an adverse effect on product quality (i.e., drug product identity, strength, quality, purity, or potency), and therefore, should be documented by applicants in an annual report under 21 CFR 314.70(d).

---

Authorizing Statute(s): None

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:
	75 FR 36421	06/25/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 65667	11/01/2013
Did the Agency receive public comments on this ICR? Yes

---

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

IC Title	Form No.	Form Name
Supplements and Annual Reports for New Drug Applications
Supplements and Annual Reports for Abbreviated New Drug Applications

---

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	2,876	0	0	2,876	0	0
Annual Time Burden (Hours)	286,150	0	0	286,150	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: This is a new collection

---

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

---

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: 11/06/2013

---