Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice

ICR 202104-0910-008

OMB: 0910-0563

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0563 202104-0910-008
Received in OIRA 201804-0910-007
HHS/FDA CDER
Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
Extension without change of a currently approved collection   No
Regular 04/14/2021
  Requested Previously Approved
36 Months From Approved 05/31/2021
1 3
30 68
0 0

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.

US Code: 21 USC 360bbb-1 Name of Law: FFDCA; Dispute Resolution
  
None

Not associated with rulemaking
Other Documents for OIRA Review

  85 FR 79186 12/09/2020
86 FR 19270 04/13/2021
No

1
IC Title Form No. Form Name
Requests for Dispute Resolution (Tier One and Tier Two)
Requests for Tier-Two Dispute Resolution

  Total Request 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 3 0 -1 -1 0
Annual Time Burden (Hours) 30 68 0 -30 -8 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
Yes
Miscellaneous Actions
Our estimated burden for the information collection reflects a decrease of 38 hours and a decrease of 1 request. This adjustment corresponds to a decrease in the number of submissions we have received over the last few years.

$1,350
No
    No
    No
No
No
No
No
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
04/14/2021


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