Guidance for Industry: Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT 0563 FINAL 12-29-2014.doc Supporting Statement A	2015-01-07

IC Document Collections

IC ID	Document Title	Status
6285	Requests for Tier-One Dispute Resolution Other-Guidance	Modified
214490	Requests for Tier-Two Dispute Resolution Other-Guidance	New

ICR Details

OMB Control No: 0910-0563	ICR Reference No: 201501-0910-001
Status: Historical Active	Previous ICR Reference No: 201109-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Guidance for Industry: Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
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: 04/06/2015
	Date Received in OIRA: 01/08/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2018	36 Months From Approved	04/30/2015
Responses	3	0	2
Time Burden (Hours)	68	0	68
Cost Burden (Dollars)	0	0	0

---

Abstract: Disputes about scientific and technical issues relating to current good manufacturing practice requirements (CGMP) may arise during FDA inspections of pharmaceutical manufacturers to determine compliance with CGMP requirements, or during FDA's assessment of corrective actions undertaken as a result of such inspections. The guidance provides procedures for raising such disputes to FDA's Office of Regulatory Affairs (ORA) and center levels and for requesting review by a dispute resolution (DR) Panel.

---

Authorizing Statute(s): US Code: 21 USC 321,351,352,355,360b,371,&374 Name of Law: FD&C 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:
	79 FR 46836	08/11/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 77010	12/23/2014
Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
Requests for Tier-Two Dispute Resolution
Requests for Tier-One Dispute Resolution

---

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	3	2	0	1	0	0
Annual Time Burden (Hours)	68	68	0	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The increased burden is the result of adding the request for Tier-Two Dispute Resolution to the burden chart.

---

Annual Cost to Federal Government: $450

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: 01/08/2015

---