Survey+Details+3-2-09

=Survey Details ( aggregated through 3/2/2009)= toc

Q1.In order to
accurately combine multiple surveys coming from your corporation, we would like to know your corporate name. Your corporate name is not used for any other purpose and will not be made public. Corporate Name:

A1. Anonymized

Q2.You may not
be familiar with the electronic SPL submission plans at the corporate level. If you are answering this survey for a particular business group, we need to collate the various group responses for your corporation. I am responding for:

A2. (1)*Redacted* Pharmaceuticals USA (2)Regulatory Affairs - Labeling Unit (3)Regulatory (4)Regulatory Affairs (5)Pharmaceuticals (6)Human Pharmaceutical (7)Regulatory Affairs/CMC (8)Human pharmaceutical, human biologic

Q5. How many
active NDC Labeler Codes does your corporation/business unit have?

A5. (1) 3 (2) 4 (3) 1 (4) 90 (5) 6 (6) 9 (7) 250 (8) 1 (9) 20 (10) 1 (11) 9 Average 35.8 (394/11)

Q6. How do you
currently store your NDC Labeler Code submission documents (Form 2656)?

A6. (Other) Both electronic and paper.

Q8. Who currently
submits Labeler Code Requests?

A8. (1) One group Regulatory Person, Two groups Labeling people (2) CMC Regulatory

Q9. In the future,
who will submit electronic Labeler Code Requests in SPL?

A9. (1) Two groups will be Regulatory person, one group will remain labeling people (2) We're not sure

Q13. How do you
plan to identify (or how did you identify) your Labeler D-U-N-S Number(s)?

A13. (1) Call D&B (2) Sales and Marketing (3) I am currently working with D&B in the US and D&B Nordic (Sweden)

Q15. How many active
Establishment sites does your corporation/business unit have?

A15.

US
(1) 1 (2) 1 (3) 1 (4) 8 (5) 9 (6) 1 (7) 2 (8) 6 (9) 1 (10) 2

Average 3.2 (32/10)

Foreign
(1) 4 (2) 8 (3) 4 (4) 4 (5) 5 (6) 6 (7) 5 (8) 14 (9) 0 (10) 7 Average 5.7 (57/10)

Q16. Are your
Establishment Registrations currently sent from one or many location(s)?

A16. only one site

Q17. How do you
currently store your Establishment Registration submission documents (Form 2656)?

A17. Both paper and electronic.

Q19. Who currently
submits Establishment Registrations for your corporate/business unit?

A19. (1) Administrative Assistant in Technical Operations (2) CMC Regulatory (3) QA Personnel

Q20. Who (in the
future) will submit electronic Establishment Registrations in SPL?

A20. (1) Not sure yet, probably CMC (2) QA Personnel

Q24. How do you
plan to identify (or how did you identify) your Registrant and Establishment site D U N S Number(s)?

A24. (1) Call D&B (2) Contact directly as well (3) Contact establishment for DUNS number. (4) Sale and Marketing (5) Working with D&B personnel.

Q27. How do you
currently store your Product Listing submission documents?

A27. Both paper and electronic.

Q29. Who currently
submits Product Listings for your corporate/business unit?

A29. One group RA, two groups labeling people

Q30. Who (in the
future) will submit electronic Product Listing(s) in SPL?

A30. Two groups RA, one grou labeling

Q33. How did you
hear about the FDA eDRL Pilot Program (choose as many as needed)?

A33. (1) spl working group, not wiki (2) Member of Drug Listng Lifecycle Team (3) Drug Listing Lifecycle Workstream

35a. Expected date
of first Labeler Code Request SPL submission (1) 2/15/2009 (2) 02/15/2009 (3) 03/31/2009 (4) 03/31/2009 (5) 04/01/2009 (6) 03/31/2009 (7) 04/01/2009

35b. Expected date
of first Establishment Registration SPL submission (1) 02/20/2009 (2) 02/15/2009 (3) 03/31/2009 (4) 03/31/2009 (5) 04/06/2009 (6) 03/31/2009 (7) 04/01/2009

35c. Expected date
of first Product Listing/Content of Labeling SPL submission (1) 03/01/2009 (2) 05/15/2009 (3) 03/31/2009 (4) 04/20/2009 (5) 04/01/2009 (6) 04/01/2009

Q36. If you are not
planning to participate in the FDA eDRL Pilot Program, please indicate why?

A36. N/A

Q40. Select the best
description of the labeling and listing activities within your corporation/business group:

A40. Answers 1&2. 1 for two labeling groups, 2 for one labeling group

Q41. How do you
expect your organization’s structure will change to effectively meet the FDA electronic submission requirement?

A41. (1) 2, 3 & 4 (2) Currently working on new internal process

Q43. How do you
expect your corporation/business unit will prepare your future electronic SPL submissions?

A43. (1) Working these details out now (2) X-Forms (3) Add new users to an exiting system that will be upgraded to meet the SPLr4 requirements (4) Currently working with a vendor to create a new tool.

44. Anonymized