1.

Notifying Member: United States of America

If applicable, name of local government involved (Article 3.2 and 7.2):  

2.

Agency responsible: Food and Drug Administration (FDA), Health and Human Services (HHS) [1139]

Name and address (including telephone and fax numbers, email and website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above: Please submit comments to: USA WTO TBT Enquiry Point, Email: usatbtep@nist.gov

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other:

4.

Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Biological products. Mathematics. Natural sciences (Vocabularies) (ICS 01.040.07), Medical sciences and health care facilities in general (ICS 11.020)

5.

Title, number of pages and language(s) of the notified document: Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products; Companion to Direct Final Rule (7 pages, in English).

6.

Description of content: The Food and Drug Administration (FDA or Agency or we) is proposing to amend the general biological products standards relating to dating periods and also to remove certain standards relating to standard preparations and limits of potency. FDA is proposing this action to update outdated requirements, and accommodate new and evolving technology and testing capabilities, without diminishing public health protections. This proposed action is part of FDA's retrospective review of its regulations in response to an Executive order.

7.

Objective and rationale, including the nature of urgent problems where applicable: Prevention of deceptive practices and consumer protection

8.

Relevant documents: 81 Federal Register (FR) 26753, 4 May 2016; Title 21 Code of Federal Regulations (CFR) Part 610.  Will appear in the Federal Register when adopted.

Direct Final Rule published 4 May 2016 will be issued as Add.1:
https://www.gpo.gov/fdsys/pkg/FR-2016-05-04/html/2016-10385.htm
https://www.gpo.gov/fdsys/pkg/FR-2016-05-04/pdf/2016-10385.pdf  

9.

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

10.

Final date for comments: 18 July 2016

11.

Texts available from: National enquiry point [  ] or address, telephone and fax numbers and email and website addresses, if available, of other body:

https://members.wto.org/crnattachments/2016/TBT/USA/16_1849_00_e.pdf