[Federal Register Volume 78, Number 90 (Thursday, May 9, 2013)]
[Proposed Rules]
[Pages 27116-27117]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-11006]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 312

[Docket No. FDA-2013-D-0447]


Draft Guidance for Industry on Charging for Investigational Drugs 
Under an Investigational New Drug Application--Questions and Answers; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Charging for 
Investigational Drugs Under an IND--Qs & As.'' This guidance is 
intended to provide information for industry, researchers, and 
physicians on how FDA is implementing its regulation on charging for an 
investigational drug under an investigational new drug (IND) 
application. FDA has received a number of questions about how it is 
implementing the charging regulation. Therefore, FDA is providing this 
draft guidance in a question and answer format, addressing the most 
frequently asked questions and answers, including questions about 
charging for investigational drugs made available under expanded access 
programs.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 8, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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 
Office of Communication, Outreach, and Development (HFM-40), Center for 
Biologics Evaluation and Research, 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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:
    For the Center for Drug Evaluation and Research:

Colleen L. Locicero, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4200, 
Silver Spring, MD 20993-0002, 301-796-2270.

    For the Center for Biologics Evaluation and Research:

Stephen M. Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852-1448, 301-827-6210.


SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Charging for Investigational Drugs Under an IND--Qs & As.'' 
In 2009, FDA amended its regulation concerning charging for 
investigational new drugs under an IND (August 13, 2009; 74 FR 40872). 
The new regulation, which went into effect on October 13, 2009, removed 
paragraph (d) of Sec.  312.7 (21 CFR 312.7) and replaced it with new 
Sec.  312.8. The new regulation is intended to clarify the 
circumstances in which charging for an investigational drug in a 
clinical trial is appropriate, to set forth criteria for charging for 
an investigational drug for the three types of expanded access for 
treatment use described in subpart I of 21 CFR part 312, and to clarify 
what costs can be recovered for an investigational drug. Elsewhere in 
this issue of the Federal Register, FDA is announcing the availability 
of the draft guidance entitled ``Expanded Access to Investigational 
Drugs for Treatment Use--Qs & As,'' which is intended to provide 
information about FDA's implementation of its expanded access 
regulations (21 CFR part 312, subpart I).
    Since Sec.  312.8 has been in effect, FDA has received numerous 
questions about how it is implementing the regulation and interpreting 
various provisions. Consistent with the goal of clarifying the 
requirements for charging for an investigational drug and the types of 
costs that can be recovered, FDA is providing a draft guidance in a 
question and answer format, addressing the most frequently asked 
questions and answers about charging for investigational drug under an 
IND.
    This draft guidance is being issued consistent with FDA's good 
guidance

[[Page 27117]]

practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on charging for 
an investigational drug under an IND. 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. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in Sec.  312.8 have been approved under OMB 
control number 0910-0014.

III. 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.

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/default, or http://www.regulations.gov.

    Dated: May 3, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-11006 Filed 5-8-13; 8:45 am]
BILLING CODE 4160-01-P