Submissions

CHPA takes this opportunity to share comments on the agency's proposed rule for Medicare, Medicaid, Children's Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests.

The industry favors and supports the development of reasonable guidance. However, the agency’s attempt to redefine the NDI notification process contradicts the letter and spirit of DSHEA. The Draft Guidance would undo nearly two decades of agency practice and policy.

Enclosed herein are comments on "Guidance for Industry: Self-Selection Studies for Nonprescription Drug Products."

CHPA comments on proposed recommendations for the reauthorization of the Prescription Drug User Fee Act.

The following comments address 1) data and information on sunscreen spray dosage forms to confirm their eligibility for inclusion in the final sunscreen monograph and 2) data and information supporting the inclusion of powder sunscreens in the final monograph.

We support the Agency's proposed decision to allow sunscreen products to be labeled with SPFs up to SPF 50+ and understand that higher SPF levels may be considered if supporting data are submitted to the Agency for review.

This letter sets forth the scientific and regulatory reasons that fluoride does not meet the Proposition 65 criteria for listing.

Comments submitted by the Consumer Healthcare Products Association and the Personal Care Products Council regarding draft guidance for industry on enforcement policy for OTC sunscreen drug products marketed without an approved application.