G/SPS/N/USA/2875  
 
29 July 2016  
(16-4051)  Page: 1/3  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION 
1. Notifying Member: UNITED STATES OF AMERICA 
If applicable, name of local government involved:   
2. Agency responsible: United States Food and Drug Administration 
3. Products covered (provide tariff item  number(s) as specified in national 
schedules deposited with the WTO; IC S numbers should be provided in 
addition, where applicable): Fish and fishery products - HS Code(s): 03 
4. Regions or countries likely to be affected , to the extent relevant or practicable: 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document: Agency Information Collection Activities; Proposed 
Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products; Notice  Language(s): English  Number of 
pages: 4 
https://www.gpo.gov/fdsys/pkg/F R-2016-07-26/pdf /2016-17571.pdf  
6. Description of content: The Food and Drug Administration is announcing an 
opportunity for public comment on the proposed collection of certain information by the 
Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Regi ster concerning each proposed collection of 
information, including each proposed extension of an existing collection of information, 
and to allow 60 days for public comment in response to the notice. This notice invites comments on the information collection provisions of our regulations requiring reporting 
and recordkeeping for processors and importers of fish and fishery products. 
7. Objective and rationale: [X] food safety, [ ] animal health, [ ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [ ] protect territory from 
other damage from pests.   
8. Is there a relevant international st andard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g. title or serial  n u m b e r  o f  C o d e x  
standard or related text)   
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[X] None Does this proposed regulation conform to the relevant international standard?   
[ ] Yes   [ ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   G/SPS/N/USA/2875 
 
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  9. Other relevant documents and language (s) in which these are available:     
10. Proposed date of adoption (dd/mm/yy) : Not applicable 
Proposed date of publication (dd/mm/yy) : Not applicable 
11. Proposed date of entry into force: [ ] Six months from date of publication , 
and/or  (dd/mm/yy) : Not applicable 
[ ] Trade facilitating measure   
12. Final date for comments: [ ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 24 September 2016 
Agency or authority designated to hand le comments: [ ] National Notification 
Authority, [ ] National Enquiry Point.  Address, fax number and e-mail address 
(if available) of other body:  
You may submit comments as follows: Electronic Submissions 
Submit electronic comments in the following way: 
Federal eRulemaking Portal: http://www.regulations.gov . Follow the instructions for 
submitting comments. Comments submitted electronically, including attachments, to 
http://www.regulations.gov  will be posted to the docket unchanged. Because your 
comment will be made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party may not wish to 
be posted, such as medical information, your or anyone else's Social Security number, 
or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on 
http://www.regulations.gov .   
If you want to submit a comment with confidential information that you do not wish to 
be made available to the public, submit the comment as a written/paper submission and 
in the manner detailed (see "Written/Paper Submissions" and "Instructions"). 
Written/Paper Submissions Submit written/paper submissions as follows: 
Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will 
post your comment, as well as any attachments, except for information submitted, 
marked and identified, as confidential, if submitted as detailed in "Instructions".  
Instructions: All submissions received must include the Docket No. FDA-2013-N-0879 for 
"Agency Information Collection Activities; Proposed Collection; Comment Request; 
Procedures for the Safe and Sanitary Proc essing and Importing of Fish and Fishery 
Products". Received comments will be placed in the docket and, except for those 
submitted as "Confidential Submissions", publicly viewable at 
http://www.regulations.gov  or at the Division of Dockets Management between 9 a.m. 
and 4 p.m., Monday through Friday.  
Confidential Submissions - To submit a comment with confidential information that you 
do not wish to be made publicly available, submit your comments only as a 
written/paper submission. You should submit two copies total. One copy will include the 
information you claim to be confidential with a heading or cover note that states "THIS 
DOCUMENT CONTAINS CONFIDENTIAL INFORM ATION". FDA will review this copy, 
including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed conf idential information redacted/blacked out, 
will be available for public viewing and posted on http://www.regulations.gov . Submit 
both copies to the Division of Dockets Management. If you do not wish your name and 
contact information to be made publicly available, you can provide this information on G/SPS/N/USA/2875 
 
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  the cover sheet and not in the body of your comments and you must identify this 
information as "confidential". Any information marked as "confidential" will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of  comments to public dockets, see 80 FR 
56469, 18 September 2015, or access the information at: http://www.fda.gov/regulator
yinformation/dockets/default.htm . 
13. Text(s) available from: [X] National Notifi cation Authority, [ ] National Enquiry 
Point. Address, fax number and e-mail address (if available) of other body:   
United States SPS National Notification Auth ority, USDA Foreign Agricultural Service, 
International Regulations and Standards Division (IRSD), Stop 1014, Washington D.C. 20250; Tel: +(1 202) 720 1301; Fax: +(1 202) 720 0433; E-mail: us.spsenquirypoint@fas.usda.gov  
Text can also be found in the Federal Register, Vol. 81, No. 143, page 48816 or on the 
internet at: https://www.gpo.gov/fdsys/pkg/F R-2016-07-26/pdf/2016-17571.pdf