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) [1004]

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:  ncsci@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): Fluoroscopic equipment; Medical equipment (ICS: 11.040)

5.

Title, number of pages and language(s) of the notified document: Performance Standards for Ionizing Radiation Emitting Products; Fluoroscopic Equipment (3 pages, in English).

6.

Description of content: The Food and Drug Administration (FDA) is proposing to amend a Federal performance standard for ionizing radiation to correct a drafting error regarding fluoroscopic equipment measurement. We are taking this action to ensure clarity and improve the accuracy of the regulations.

7.

Objective and rationale, including the nature of urgent problems where applicable: Protection of Human health or Safety

8.

Relevant documents: 80 Federal Register (FR) 19589, 13 April 2015; Title 21 Code of Federal Regulations (CFR) Part 1020.  Will appear in the Federal Register when adopted. A direct final rule was issued 13 April 2015 and will be issued as Add.1:

http://www.gpo.gov/fdsys/pkg/FR-2015-04-13/html/2015-08360.htm
http://www.gpo.gov/fdsys/pkg/FR-2015-04-13/pdf/2015-08360.pdf  

9.

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

10.

Final date for comments: 29 June 2015

11.

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

http://www.gpo.gov/fdsys/pkg/FR-2015-04-13/html/2015-08361.htm

http://www.gpo.gov/fdsys/pkg/FR-2015-04-13/pdf/2015-08361.pdf