Download:
pdf |
pdfSubmit by Email
Print Form
Form Approved
OMB Number 0910-0621
Expiration Date: xx/xx/xxxx
(See Public Reporting Burden
Statement on page 2.)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Voluntary National Retail Food Regulatory Program Standards
FDA NATIONAL REGISTRY REPORT
1. Information about the Jurisdiction
Name of Jurisdiction Reporting
This Information
Address
City
State
Title for Contact Person
Contact Person for Jurisdiction
ZIP Code
Phone Number for Jurisdiction's
Contact Person
E-Mail Address for Jurisdiction's Contact Person
Jurisdiction is willing to serve as an auditor
for another jurisdiction:
Website Link for Jurisdiction
Yes
2. Information about Enrollment
No
Enrollment Date (DD/MM/YYYY)
Please enroll this jurisdiction in the Retail Program Standards
Please remove this jurisdiction from the Listing of Enrolled Jurisdictions
Update Results for the
Self-Assessment.
Other - Please explain
3. Information about Self-Assessment Findings and Verification Audit Findings
Completion Date for Self-Assessment
Program
Standard
Number
Instructions for Completing this Section
** If the jurisdiction's self-assessment indicates
conformance with any Standards, please mark
the applicable Standards. Only enter a date
if it differs from that of the self-assessment
completion date (i.e. a self-assessment update
was conducted)
*** If the jurisdiction's verification audit
confirms conformance with any Standards,
please mark the applicable Standards and
indicate the completion date.
**** All dates should be entered in the
MM/DD/YYYY format.
Self-Assessment**
Verification Audit***
Program Standard Met
(Mark all that apply)
Verification Audit Confirmed
(Mark all that apply and enter the
date confirmed for each)
1
2
3
4
5
6
7
8
9
4. Permission to Publish Information on the FDA Website
Permission is granted to publish the following information in the Listing of Jurisdictions Enrolled in the Voluntary National Retail Food
Regulatory Program Standards:
Enrollment information
Authorized Individual (Printed)
FORM FDA 3958 (11/16)
Title
Self-assessment findings
Signature
Page 1 of 2
Verification audit findings
Date (mm/dd/yyyy)
PSC Publishing Services (301) 443-6740
EF
Instructions for Completing FDA National Registry Report - Form 3958
The FDA National Registry Report must be completed and submitted to the appropriate FDA Regional Retail Food Specialist (Retail
Food Specialist) within 30 days following completion of the self-assessment, self-assessment update, or verification audit. The Listing
of Jurisdictions Enrolled in the Voluntary National Retail Food Regulatory Program Standards will be updated using data contained in
this report.
This form may be completed online and printed for submission to the appropriate Retail Food Specialist. Alternatively, this form may be
completed online and submitted electronically to the appropriate Retail Food Specialist. A listing of Retail Food Specialists, by state,
can be found on FDA's Retail Program Standards website (www.fda.gov/RetailProgramStandards).
Part 1: Information about the Jurisdiction
1. Enter the jurisdiction name, and the jurisdiction address.
2. Enter the name and contact information for the contact person for this jurisdiction. This is the individual to whom Retail Program
Standards correspondence will be sent.
3. Enter the jurisdiction's website address.
4. Indicate if the jurisdiction is willing to serve as an auditor for another jurisdiction.
Part 2: Information about Enrollment
1. Select the first box to indicate that the jurisdiction is a new enrollee. Please also enter the enrollment date.
2. Select the second box to indicate that you would like to remove this jurisdiction from the Listing of Jurisdictions Enrolled in the
Voluntary National Retail Food Regulatory Program Standards.
3. Select the third box to indicate that you are updating the findings from your self-assessment or verification audit. If you are
updating this information please select the relevant self-assessment.
4. If the first three options are not applicable, select "Other" and provide additional information.
Part 3: Information about Self-Assessment Findings and Verification Audit Findings
1. Enter the date that the self-assessment was completed.
2. Check the applicable boxes to indicate which Standards were met, as determined by the self-assessment. For each box that is
checked, do not enter a date unless the self-assessment date for that Standard is different than the date that the self-assessment
was completed (i.e. a self-assessment update was completed for Standard X after the self-assessment was completed.)
3. Check the applicable boxes in the third column to indicate which Standards were met, as verified by a verification audit. For each
box that is checked, a date should be entered to indicate the date that the verification audit was completed for that Standard.
Part 4: Permission to Publish Information on FDA's Website
1. With your permission, information submitted on this form will be published on FDA's Listing of Jurisdictions Enrolled in the
Voluntary National Retail Food Regulatory Program Standards. Check the appropriate box(es) to indicate what information FDA
may publish on the website.
After completing Parts 1-4, the Program Manager must:
1. Enter the name of the Authorized Individual. This may be the Program Manager or another individual authorized to submit this
information.
2. Provide the signature of the Authorized Individual for the reporting jurisdiction.
a. If the form is completed electronically, click the signature box to provide an electronic signature.
b. If the form is completed by hand, sign your name in the signature box.
3. Enter the date that the form is signed.
FOR INTERNAL FDA USE ONLY (To be completed by FDA Regional Retail Food Specialist)
The Listing of Enrolled Jurisdictions should reflect the following changes:
New Enrollment
Remove jurisdiction from Listing of Enrolled Jurisdictions (please attach an explanation)
New/Updated Jurisdiction Contact Information
New/Updated Jurisdiction Website Address
Updated Results for the indicated Self-Assessment Period
Reviewed By
Submitted By
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF ADDRESS BELOW.*
This section applies only to the requirements of the Paperwork Reduction Act of 1995: The public reporting burden time for this
collection of information is estimated to average 12 minutes per response, including the time to review instructions, search existing data
sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden
estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Operations
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
FORM FDA 3958 (11/16)
Do not send your completed form to the PRA Staff email address to the left.
“An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it
displays a currently valid OMB number.”
Page 2 of 2
File Type | application/pdf |
File Title | FORM FDA 3958 |
Subject | FDA National Registry Report |
Author | PSC Publishing Services |
File Modified | 2017-06-28 |
File Created | 2017-06-26 |