[Federal Register Volume 77, Number 64 (Tuesday, April 3, 2012)]
[Notices]
[Pages 20025-20026]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-7912]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0300]


Draft Guidance for Industry on Compliance Policy for Reporting 
Drug Sample Distribution Information; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Compliance 
Policy on Reporting Drug Sample Distribution Information Under the 
Affordable Care Act.'' This draft guidance is intended to provide 
information regarding the Agency's implementation of the drug sample 
transparency reporting provisions of section 6004 of the Patient 
Protection and Affordable Care Act. The draft guidance notifies 
entities covered by the reporting obligations in section 6004 that FDA 
does not intend to object until at least October 1, 2012, if 
manufacturers and authorized distributors of record (ADRs) do not 
submit information under those reporting provisions and that the Agency 
intends to provide notice before revising its exercise of discretion 
with respect to compliance.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit electronic or written comments on the draft guidance 
by June 4, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002 or to 
the Office of Communication, Outreach and Development (HFM-40), Center 
for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Donovan F. Duggan, Jr., Center for 
Drug Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 4288, Silver Spring, MD 20993-0002, 301-
796-0584; Paul Loebach, Center for Drug Evaluation and Research, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4268, 
Silver Spring, MD 20993-0002, 301-796-2173; or Stephen Ripley, Center 
for Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Compliance Policy on Reporting Drug Sample Distribution 
Information.'' On March 23, 2010, the Affordable Care Act was signed 
into law. Among its many provisions, section 6004 of the Affordable 
Care Act amended the Social Security Act by adding section 1128H (42 
U.S.C. 1320a-7i). This new section requires the submission of certain 
drug sample information to FDA not later than April 1 of each year, 
beginning April 1, 2012.
    The draft guidance is intended to provide information regarding the 
Agency's implementation of section

[[Page 20026]]

6004. The draft guidance notifies entities covered by section 6004 that 
FDA does not intend to object until at least October 1, 2012, if 
manufacturers and ADRs do not submit information under section 6004 and 
that we intend to provide notice before revising our exercise of 
discretion with respect to compliance. The draft guidance also notifies 
covered entities that FDA plans to use its Electronic Submission 
Gateway (the Gateway) for submissions under section 6004 and that 
revisions to allow the Gateway to receive such submissions should be 
complete by April 1, 2012. Should covered entities wish to make such 
submissions notwithstanding FDA's compliance policy, the draft guidance 
provides information about accessing the Gateway. The Agency expects to 
issue further draft guidance concerning the requirements of section 
6004 later in 2012.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on this topic. 
It does not create or confer any rights for or on any person and does 
not operate to bind FDA or the public. An alternative approach may be 
used if such approach satisfies the requirements of the applicable 
statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Paperwork Reduction Act of 1995

    This draft guidance regarding Agency compliance policy refers to 
information collections under section 6004 that are subject to review 
by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). As noted, the 
Agency is also preparing a draft guidance for release later this year 
to provide additional information regarding submissions under section 
6004. In accordance with the PRA, prior to publication of a final 
guidance document, FDA intends to solicit public comment and obtain OMB 
approval for any new information collections under section 6004.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
http://www.regulations.gov.

    Dated: March 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-7912 Filed 3-29-12; 11:15 am]
BILLING CODE 4160-01-P