Submissions

CHPA appreciates the opportunity to provide the National Osteoporosis Foundation with comments on their recently released "Position Statement on Calcium and Cardiovascular Disease" as well as the Evidence Report on which it is based.

While the monograph system has served our nation well, it has become cumbersome and outdated and needs to be modernized.

CHPA comments on the Agency’s review and action on OTC time and extent applications. This proposed rule would supplement the time and extent application process for OTC drugs by establishing timelines and performance metrics for the Agency’s review of non-sunscreen TEAs.

CHPA appreciates the opportunity to provide information relevant to use of the term “natural” in food labeling, and believes that a formal definition will help to reduce consumer confusion and provide clarity to manufacturers and marketers making claims relying upon such a definition.

These comments are submitted on behalf of CHPA in response to the National Institutes of Health notice entitled, “Nominations to the Report on Carcinogens and Office of Health Assessment and Translation; Request for Information”.

In general, CHPA supports FDA's intent to harmonize the requirements for Rx and OTC products and make them consistent with long-standing Agency policy.

Comments regarding guidance for industry pertaining to sunscreen ingredients requesting inclusion into the OTC sunscreen monograph.

Enclosed herein are comments on "Guidance for Industry; Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process."

Enclosed herein are comments on "Guidance for Industry; Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request", published as Draft Guidance.

Enclosed herein are comments on "Guidance for Industry; Nonprescription Sunscreen Drug Products - Content and Format of Data Submissions to Support a GRASE determination Under the Sunscreen Innovation Act."