Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records

ICR 201512-0910-007

OMB: 0910-0811

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0811 201512-0910-007
Historical Active
HHS/FDA CFSAN
Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 03/24/2016
Retrieve Notice of Action (NOA) 01/28/2016
  Inventory as of this Action Requested Previously Approved
03/31/2019 36 Months From Approved
1,799 0 0
25,651 0 0
395,389 0 0

Respondents to the collection are manufacturers of exempt infant formula who choose to comply with agency guidance. The guidance recommends recordkeeping that FDA believes will help ensure the safety and efficacy of these products.

None
None

Not associated with rulemaking
Other Documents for OIRA Review

  80 FR 14134 03/18/2015
81 FR 4917 01/28/2016
Yes

2
IC Title Form No. Form Name
Recurring Current Good Manufacturing Practice (CGMP) Controls Recordkeeping
One time recordkeeping for first year

  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 1,799 0 0 1,799 0 0
Annual Time Burden (Hours) 25,651 0 0 25,651 0 0
Annual Cost Burden (Dollars) 395,389 0 0 395,389 0 0
Yes
Miscellaneous Actions
No
This is a new information collection request in support of agency guidance.

$0
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 [email protected]

  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.
01/28/2016


© 2024 OMB.report | Privacy Policy