The FDA has released draft guidance on implementation of the drug sample transparency reporting provisions of section 6004 of the ACA. Under this provision, beginning April 1, 2012 and annually thereafter, each manufacturer and authorized distributor of record (ADR) of a prescription drug for which payment is available under Medicare or Medicaid must submit to the Secretary, for the preceding year, the identity and quantity of drug samples requested and distributed under the federal Food, Drug, and Cosmetic Act, aggregated by the name, address, professional designation, and signature of the practitioner making the request, or of any individual who makes or signs for the request on behalf of the practitioner (and by any other category of information determined appropriate by the Secretary). Notably, the FDA is has announced that, notwithstanding the statutory deadline, FDA does not intend to object until at least October 1, 2012, if manufacturers and ADRs do not submit information under those reporting provisions. The FDA intends to provide notice before revising its exercise of discretion with respect to compliance, and the agency expects to issue additional guidance concerning the section 6004 later in 2012. The draft guidance also notifies covered entities that (1) FDA plans to use its Electronic Submission Gateway for submissions under section 6004; (2) revisions to allow the Gateway to receive such submissions should be complete by April 1, 2012; and (3) if covered entities wish to make submissions despite FDA’s compliance policy, the draft guidance provides information about accessing the Gateway.  A Federal Register notice announcing the availability of the guidance will be published April 3, and comments will be accepted for 60 days thereafter.