[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draft guidance issued in May 2013.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