Document ID: FDA-2014-N-1459-0029
Agency: fda
Document Type: Notice
Title: Memorandum of Understanding Addressing Certain Distributions of
Compounded Human Drug Products Between the States and the Food and Drug Administration; Extension of Comment Period
Posted Date: 2015-06-03T04:00Z

[Federal Register Volume 80, Number 106 (Wednesday, June 3, 2015)]
[Notices]
[Page 31604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13466]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1459]

Memorandum of Understanding Addressing Certain Distributions of 
Compounded Human Drug Products Between the States and the Food and Drug 
Administration; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is extending 
the comment period in the notice of availability that appeared in the 
Federal Register of February 19, 2015. In that notice of availability, 
FDA requested comments on a draft standard memorandum of understanding 
(MOU) entitled ``Memorandum of Understanding Addressing Certain 
Distributions of Compounded Human Drug Products Between the State of 
[insert State] and the U.S. Food and Drug Administration.'' The draft 
standard MOU describes the responsibilities of any State that chooses 
to sign the MOU in investigating and responding to complaints related 
to compounded human drug products distributed outside the State and in 
addressing the interstate distribution of inordinate amounts of 
compounded human drug products. The Agency is taking this action to 
allow interested persons additional time to submit comments.

DATES: FDA is extending the comment period in the notice of 
availability published on February 19, 2015 (80 FR 8874) which includes 
comment on information collection issues under the Paperwork Reduction 
Act of 1995 (the PRA). Submit either electronic or written comments on 
the draft standard MOU or on information collection issues under the 
PRA by July 20, 2015.

ADDRESSES: Submit written requests for single copies of the MOU to 
Edisa Gozun, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, suite 5100, Silver 
Spring, MD 20993-0002. Send one self-addressed label to assist that 
office in processing your request. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the draft standard MOU.
    Submit electronic comments on the new draft standard MOU or on the 
collection of information 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: Edisa Gozun, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, suite 5100, Silver Spring, MD 20993-0002, 
301-796-3110.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of February 19, 2015 (80 FR 8874), FDA 
published a notice of availability of a draft standard MOU entitled 
``Memorandum of Understanding Addressing Certain Distributions of 
Compounded Human Drug Products Between the State of [insert State] and 
the U.S. Food and Drug Administration'' with a 120-day comment period 
to request comments on the draft standard MOU. The draft standard MOU 
describes the responsibilities of any State that chooses to sign the 
MOU in: (1) Investigating and responding to complaints related to 
compounded human drug products distributed outside the State and (2) 
addressing the interstate distribution of inordinate amounts of 
compounded human drug products. Comments were also requested on 
information collection issues under the PRA. The notice of availability 
also announced the withdrawal, effective February 19, 2015, of an 
earlier draft standard MOU entitled ``Memorandum of Understanding on 
Interstate Distribution of Compounded Drug Products'' that published on 
January 21, 1999 (64 FR 3301). The January 1999 draft standard MOU is 
superseded by the February 2015 draft standard MOU.
    The Agency is extending the comment period both for the draft 
standard MOU and for information collection issues under the PRA for 30 
days, until July 20, 2015. The Agency believes that a 30-day extension 
allows adequate time for interested persons to submit comments without 
significantly delaying resolution of these important issues.

II. Request for Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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.

III. Electronic Access

    Persons with access to the Internet may obtain the draft standard 
MOU at http://www.regulations.gov.

    Dated: May 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13466 Filed 6-2-15; 8:45 am]
BILLING CODE 4164-01-P