Survey Reminder

Appendix 1.2

Survey Reminder

[From ERG to potential respondents. To be sent 7-14 days after mailing pre-notification letter from Thomas Henry.]

Subject: FDA invites you to take a survey of drug product manufacturing practices

Dear Mr./Ms./Dr.,

My company, Eastern Research Group, Inc. (ERG), has been contracted by the Food and Drug Administration to implement a survey of domestic and foreign-based facilities that are registered with FDA as manufacturers, packers, labelers, and/or sterilizers of drug products marketed in the U.S. The purpose of the survey is to gather industry-wide data on current drug production and good manufacturing processes.

You may have recently received a letter from Thomas Henry at FDA regarding this survey.

Please note that the survey is unrelated to any of FDA’s compliance activities; the survey’s results will be aggregated and used to aid FDA’s decision-making on possible policy alternatives and to aid its economic analysis of the drug processing industry. ERG maintains the privacy of survey respondents and will not identify any individual or company responding to this survey to FDA. (If you would like to know more about ERG’s privacy policy regarding survey respondents and responses, please let me know.)

We expect the survey to require up to an hour of your time, depending on the types of drug processing activities at your facility. Please note that the survey is voluntary, not mandatory; it is, however, a chance for your voice to be heard by FDA.

To access the secure online survey login page, please click on the following direct link:

https://erg.qualtrics.com/jfe/form

Your password: 111111

If you have questions for FDA concerning this study, please call or email Thomas Henry in the FDA’s Office of the Commissioner, at 240-402-5049/Thomas.Henry@fda.hhs.gov. Ms. Henry is the FDA Supervisory Economist overseeing this work by ERG.

Thank you for your time and consideration regarding this important matter. Your feedback will be instrumental in ensuring that the data we collect on current drug processing practices will be as accurate as possible. We look forward to receiving your survey soon! Please do not hesitate to contact me if you have any questions.

Best regards,

Andreas Lord

This work is covered under Contract No. HHSF223201400008I, Task Order No. HHSF22301007T.

OMB Control No. xxxx/xxxx. Approval expires xx/xx/202x.