[Federal Register Volume 78, Number 52 (Monday, March 18, 2013)]
[Notices]
[Pages 16679-16680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-06142]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0206]


Center for Drug Evaluation and Research Medical Policy Council; 
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket, request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
establishment of a docket to receive suggestions, recommendations, and 
comments for topics from interested parties, including academic 
institutions, regulated industry, patient representatives, and other 
interested organizations, on medical policy issues that may be 
considered by the CDER Medical Policy Council (Council) in FDA's Center 
for Drug Evaluation and Research (CDER). These comments will help the 
Agency identify and address medical policy issues that need 
clarification through guidance, notice and comment procedures, or other 
means.

DATES: Submit either electronic or written comments by July 16, 2013.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
301), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. Identify comments with the docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Sandra J. Benton, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301-
796-1042, FAX: 301-847-3529, email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In January 2012, CDER established the Council to ensure better 
coordination of medical policy development and implementation within 
CDER and consistent, predictable communication of medical policy 
decisions to the public through guidance, notice and comment 
procedures, or other means.
    Chaired by CDER's Associate Director for Medical Policy, the 
Council provides a senior-level forum through which medical policy 
issues can be raised, considered, developed, and implemented. Council 
members include the following senior clinical leaders: The Center 
Director, the Deputy Center Director for Clinical Science, the Director 
of the Office of New Drugs, and the Director of the Office of 
Surveillance and Epidemiology. Experts from within CDER and other FDA 
offices provide expertise as needed for specific policy topics under 
consideration. By establishing this docket, FDA encourages the public 
to recommend specific topics for consideration by the Council. The 
Agency believes that this process will also ensure additional 
transparency in CDER's approach to medical policy development and 
implementation.

II. Range of Medical Policy Issues To Be Considered

    FDA envisions a variety of topics that may be relevant for 
consideration by the Council. Specific topics could address issues 
related to the following: (1) Clinical evidence of effectiveness or 
safety, (2) clinical study/trial design, (3) professional and patient 
labeling, (4) prescription drug promotion, (5) human subjects 
protection, (6) bioresearch monitoring, (7) good clinical practice, (8) 
counter-terrorism drug development (such as in the application of the 
Animal Rule, 21 CFR 314.600), and (9) postmarketing surveillance. To be 
considered by the Council, a medical policy issue typically would meet 
one or more of the following criteria:
     A novel medical policy issue requiring senior management 
input;
     An issue on which CDER seems to have taken inconsistent 
positions;
     An existing medical policy position that should be 
reconsidered in light of scientific or regulatory advances;
     A complex safety management issue requiring senior 
management input;
     A medical policy that may be triggered by a specific 
product, but that will be applicable to other products; or
     Strategies for implementation of a new policy.

III. Establishment of a Docket and Request for Comments

    FDA is requesting public suggestions, recommendations, and comments 
for topics (including scientific, clinical, regulatory, or other 
topics) on existing or novel medical policy issues that may warrant 
consideration by the Council. Comments should describe the following: 
(1) The medical policy issue recommended for discussion, (2) the 
rationale for doing so (e.g., clarifying previous advice or precedents, 
reconciling apparently differing perspectives within CDER or between 
CDER and regulated industry), (3) recommendations on how the medical 
policy issue could be addressed or implemented; and (4) existing policy 
documents (e.g., final guidance) relevant to the medical policy issue. 
Note that policy issues concerning any draft guidance should be 
submitted to the docket for that draft guidance.
    The Agency will carefully consider all comments submitted. FDA 
generally will not respond directly to the person or organization 
submitting the

[[Page 16680]]

comment. In general, medical policy decisions reached by the Council 
are communicated and implemented in accordance with FDA's good guidance 
practices regulation (21 CFR 10.115) or notice and comment procedures.

IV. Request for Comments

    Interested persons may submit either written comments regarding 
this notice to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: March 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06142 Filed 3-15-13; 8:45 am]
BILLING CODE 4160-01-P