[Federal Register Volume 81, Number 107 (Friday, June 3, 2016)]
[Notices]
[Pages 35779-35781]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13166]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry entitled ``Charging for 
Investigational Drugs Under an IND--Questions and Answers.'' The 
guidance provides information for industry, researchers, physicians, 
institutional review boards (IRBs), and patients about the 
implementation of FDA's regulation on charging for investigational 
drugs under an investigational new drug application (IND) for the 
purpose of either clinical trials or expanded access for treatment use. 
FDA received a number of questions concerning its implementation of the 
charging regulation. FDA is providing guidance in a question and answer 
format to address the most frequently asked questions about charging 
for investigational drugs under an IND. This guidance finalizes the 
draft guidance issued in May 2013.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or

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anyone else's Social Security number, or confidential business 
information, such as a manufacturing process. Please note that if you 
include your name, contact information, or other information that 
identifies you in the body of your comments, that information will be 
posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-D-0447 for ``Charging for Investigational Drugs Under an IND--
Questions and Answers; Guidance for Industry; Availability.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Ebla Ali Ibrahim, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6302, Silver Spring, MD 20993, 301-796-
3691; or Stephen Ripley, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 
7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Charging for Investigational Drugs Under an IND--Questions 
and Answers.'' In 2009, FDA amended the regulation concerning charging 
for investigational new drugs under an IND (74 FR 40872, August 13, 
2009). The new regulation, which went into effect on October 13, 2009, 
removed paragraph (d) of Sec.  312.7 (21 CFR 312.7(d)) and replaced it 
with new Sec.  312.8. The guidance clarifies the circumstances in which 
charging for an investigational drug under an IND for the purpose of 
clinical trials is appropriate and also sets forth criteria for 
charging for an investigational drug for the three types of expanded 
access for treatment use described in 21 CFR part 312, subpart I, and 
clarifies what costs can be recovered for an investigational drug.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
the availability of a guidance for industry entitled ``Expanded Access 
to Investigational Drugs for Treatment Use--Questions and Answers,'' 
which provides answers to questions concerning the implementation of 
FDA's regulations on expanded access to investigational drugs for 
treatment use (part 312, subpart I). (FDA's guidance documents are 
available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. FDA has 
verified the Web site addresses throughout this document, as of the 
date this document publishes in the Federal Register, but Web sites are 
subject to change over time.)
    Additionally, in this issue of the Federal Register, FDA is 
announcing the availability of a guidance for industry entitled 
``Individual Patient Expanded Access Applications: Form FDA 3926.'' 
That guidance describes Form FDA 3926 (Individual Patient Expanded 
Access--Investigational New Drug Application (IND)), which is available 
for licensed physicians to use for expanded access requests for 
individual patient INDs as a streamlined alternative to Form FDA 1571 
(IND), and describes the process for submitting expanded access 
requests for individual patient INDs.
    Since Sec.  312.8 has been in effect, FDA has received numerous 
questions about its implementation of the charging regulation. 
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 guidance in a question and answer format, 
addressing the most frequently asked questions and answers about 
charging for an investigational drug under an IND.
    In the Federal Register of May 9, 2013 (78 FR 27116), FDA announced 
the availability of the draft guidance entitled ``Charging for 
Investigational Drugs Under an IND--Qs & As.'' FDA received several 
comments on the draft guidance, and those comments were considered as 
the guidance was finalized. Based on public comments, in addition to 
editorial changes primarily

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for clarification, the major changes made to the guidance include 
adding clarification about charging for certain administrative costs in 
individual patient expanded access INDs and protocols, and the timing 
for submitting a request to FDA to reauthorize charging.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on charging for investigational drugs under an 
IND. It does not establish any rights for any person and is not binding 
on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This 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 21 CFR 312.8 and 312.320 have been 
approved under OMB control number 0910-0014.

III. Electronic Access

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

    Dated: May 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13166 Filed 6-2-16; 8:45 am]
 BILLING CODE 4164-01-P