Transmittal Of Periodic Reports
Download a blank fillable Transmittal Of Periodic Reports in PDF format just by clicking the "DOWNLOAD PDF" button.
Open the file in any PDF-viewing software. Adobe Reader or any alternative for Windows or MacOS are required to access and complete fillable content.
Complete Transmittal Of Periodic Reports with your personal data - all interactive fields are highlighted in places where you should type, access drop-down lists or select multiple-choice options.
Some fillable PDF-files have the option of saving the completed form that contains your own data for later use or sending it out straight away.
ADVERTISEMENT
1
2
3Form Approved: OMB No. 0910-0284
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Exp. Date: 2/28/2018. See PRA statement on pg. 3.
Food and Drug Administration
TRANSMITTAL OF PERIODIC REPORTS
Note: Required by 21 CFR 514.80. Failure to make the
reports is a basis for withdrawal of the NADA/ANADA.
AND PROMOTIONAL MATERIAL
1. NADA NO. or ANADA NO.
FOR NEW ANIMAL DRUGS
(See Instructions on Back)
2. Name of Applicant
3. Date Report Submitted 4. Date Report Due
5. Drug Trade Name
6. Chemical Name
7. Combined Report (List NADA numbers involved. See Instructions.)
8. Report Period
(MM) (DD) (YYYY)
(MM) (DD) (YYYY)
From:
To:
9. Type of Report (Check One)
6/12/18/24 Month
Annual
Promo/Ad
Follow Up
Other (specify)
Information Required – Periodic and Special
10.
(See CFR 514.80. Check Column A if “None.”)
A – None
B – None
C – Description (Volume Number(s), Tab(s), Pages of Report)
(1) Total No. of
(2) No. of
(3) No. of Complaints
(4) No. of
Reports
Product Defects
Affecting Animals
Animals Reacted
(a) Adverse Drug
Experiences
(b) Clinical Data (Animal
Experience)
(c) Mailing Pieces and/or
Advertising Material
(d) Current Package
Please Provide on Separate Sheet
Labeling
(e) Quantity Marketed
Please Provide on Separate Sheet
11.
Information Required – Promotional Material Only
A – Date of Issuance
B – Type of Material
C – Identification (Code No., etc.)
12. Name/Title of Responsible Official/US Agent (Type of Print)
15. Return Address of Applicant/Agent
13. Signature of Above Official/Agent
14. Email Address
16. Telephone & Fax Number of Applicant/Agent
FORM FDA 2301 (10/15)
Previous Edition is Obsolete
Page 1 of 3
EF
PSC Publishing Services (301) 443-6740
ADVERTISEMENT
0 votes
Related Articles
Related forms
Related Categories
Parent category: Business