81 FR 35779 - Charging for Investigational Drugs Under an Investigational New Drug Application-Questions and Answers; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 107 (June 3, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 107 (June 3, 2016)
| Page Range | 35779-35781 | |
| FR Document | 2016-13166 |
[Federal Register Volume 81, Number 107 (Friday, June 3, 2016)] [Notices] [Pages 35779-35781] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-13166] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 This guidance finalizes the draft guidance issued in May 2013.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 [[Page 35780]] 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 [[Page 35781]] 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
![Federal Register / Vol. 81, No. 107 / Friday, June 3, 2016 / Notices 35779
protocol amendment to an existing IND in a question and answer format to Dated: May 31, 2016.
by the sponsor of the existing IND); and address questions about how FDA is Leslie Kux,
(3) expanded access for widespread implementing its expanded access Associate Commissioner for Policy.
treatment use through a treatment IND regulations, including questions about [FR Doc. 2016–13165 Filed 6–2–16; 8:45 am]
or treatment protocol (designed for use when it is appropriate to request BILLING CODE 4164–01–P
in larger patient populations). The expanded access under each of the three
regulations are intended to facilitate, expanded access categories, the types
when appropriate, the availability of and content of expanded access DEPARTMENT OF HEALTH AND
investigational new drugs outside of a submissions, IRB review of individual HUMAN SERVICES
clinical investigation or approved drugs
patient expanded access, and the onset
where availability is limited by a risk Food and Drug Administration
and duration of expanded access use.
evaluation and mitigation strategy [Docket No. FDA–2013–D–0447]
(REMS) to patients with serious or In the Federal Register of May 9, 2013
immediately life-threatening diseases or (78 FR 27115), FDA announced the Charging for Investigational Drugs
conditions who lack other therapeutic availability of the draft guidance Under an Investigational New Drug
options. entitled ‘‘Expanded Access to Application—Questions and Answers;
Elsewhere in this issue of the Federal Investigational Drugs for Treatment Guidance for Industry; Availability
Register, FDA is announcing the Use—Questions & Answers.’’ FDA
availability of a guidance for industry received several comments on the draft AGENCY: Food and Drug Administration,
entitled ‘‘Charging for Investigational HHS.
guidance, and those comments were
Drugs Under an IND—Questions and considered as the guidance was ACTION: Notice of availability.
Answers,’’ which provides information finalized. Based on public comments, in
about the implementation of FDA’s SUMMARY: The Food and Drug
addition to editorial changes made Administration (FDA or Agency) is
regulation on charging for
primarily for clarification, the final announcing the availability of a
investigational drugs under an IND,
guidance includes significant guidance for industry entitled ‘‘Charging
including investigational drugs made
available for expanded access use. clarification on the types of expanded for Investigational Drugs Under an
(FDA’s guidance documents are access and when each type should be IND—Questions and Answers.’’ The
available at http://www.fda.gov/Drugs/ used. guidance provides information for
GuidanceComplianceRegulatory This guidance is being issued industry, researchers, physicians,
Information/Guidances/default.htm. consistent with FDA’s good guidance institutional review boards (IRBs), and
FDA has verified the Web site addresses patients about the implementation of
practices regulation (21 CFR 10.115).
throughout this document, as of the date FDA’s regulation on charging for
The guidance represents the current
this document publishes in the Federal investigational drugs under an
thinking of FDA on expanded access to
Register, but Web sites are subject to investigational new drug application
investigational drugs for treatment use. (IND) for the purpose of either clinical
change over time.) It does not establish any rights for any
Additionally, in this issue of the trials or expanded access for treatment
person and is not binding on FDA or the use. FDA received a number of
Federal Register, FDA is announcing public. You can use an alternative
the availability of a guidance for questions concerning its
approach if it satisfies the requirements implementation of the charging
industry entitled ‘‘Individual Patient
of the applicable statutes and regulation. FDA is providing guidance
Expanded Access Applications: Form
regulations. in a question and answer format to
FDA 3926.’’ The guidance describes
Form FDA 3926 (Individual Patient II. Paperwork Reduction Act of 1995 address the most frequently asked
Expanded Access—Investigational New questions about charging for
Drug Application (IND)), which is This guidance refers to previously investigational drugs under an IND.
available for licensed physicians to use approved collections of information This guidance finalizes the draft
for expanded access requests for found in FDA regulations. These guidance issued in May 2013.
individual patient INDs as a streamlined collections of information are subject to DATES: Submit either electronic or
alternative to Form FDA 1571 review by the Office of Management and written comments on Agency guidances
(Investigational New Drug Application Budget (OMB) under the Paperwork at any time.
(IND)), and describes the process for Reduction Act of 1995 (44 U.S.C. 3501– ADDRESSES: You may submit comments
submitting expanded access requests for 3520). The collections of information in as follows:
individual patient expanded access 21 CFR part 312 have been approved
INDs. Electronic Submissions
under OMB control number 0910–0014,
One of FDA’s major goals in and the collection of information Submit electronic comments in the
promulgating the expanded access resulting from the submission of Form following way:
regulations was to make expanded FDA 3926 has been approved under • Federal eRulemaking Portal: http://
access a more transparent process by www.regulations.gov. Follow the
OMB control number 0910–0814.
increasing awareness and knowledge instructions for submitting comments.
about expanded access and the III. Electronic Access Comments submitted electronically,
procedures for obtaining investigational including attachments, to http://
drugs for treatment use. Since the Persons with access to the Internet www.regulations.gov will be posted to
mstockstill on DSK3G9T082PROD with NOTICES
expanded access regulations went into may obtain the document at http:// the docket unchanged. Because your
effect in 2009, FDA has received a www.fda.gov/RegulatoryInformation/ comment will be made public, you are
number of questions concerning Guidances/default.htm, http:// solely responsible for ensuring that your
implementation of the regulations. www.fda.gov/BiologicsBloodVaccines/ comment does not include any
Consistent with the goal of making GuidanceComplianceRegulatory confidential information that you or a
expanded access processes more Information/Guidances/default.htm or third party may not wish to be posted,
transparent, FDA is providing guidance http://www.regulations.gov. such as medical information, your or
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![Federal Register / Vol. 81, No. 107 / Friday, June 3, 2016 / Notices 35781
for clarification, the major changes guidance entitled ‘‘E18 Genomic • Mail/Hand delivery/Courier (for
made to the guidance include adding Sampling and Management of Genomic written/paper submissions): Division of
clarification about charging for certain Data.’’ The draft guidance was prepared Dockets Management (HFA–305), Food
administrative costs in individual under the auspices of the International and Drug Administration, 5630 Fishers
patient expanded access INDs and Council for Harmonisation (ICH), Lane, Rm. 1061, Rockville, MD 20852.
protocols, and the timing for submitting formerly the International Conference • For written/paper comments
a request to FDA to reauthorize on Harmonisation. The draft guidance submitted to the Division of Dockets
charging. pertains to genomic sampling and to the Management, FDA will post your
This guidance is being issued management of genomic data in clinical comment, as well as any attachments,
consistent with FDA’s good guidance studies. The focus of this draft guidance except for information submitted,
practices regulation (21 CFR 10.115). is on the general principles of marked and identified, as confidential,
The guidance represents the current collecting, processing, transporting, if submitted as detailed in
thinking of FDA on charging for storing, and disposing of genomic ‘‘Instructions.’’
investigational drugs under an IND. It samples or data. The technical aspects Instructions: All submissions received
does not establish any rights for any of genomic sampling and research are must include the Docket No. FDA–
person and is not binding on FDA or the also discussed when appropriate, 2016–D–1255 for ‘‘E18 Genomic
public. You can use an alternative recognizing the rapidly evolving Sampling and Management of Genomic
approach if it satisfies the requirements technological advances in these areas. Data.’’ Received comments will be
of the applicable statutes and The draft guidance is intended to placed in the docket and, except for
regulations. provide harmonized principles of those submitted as ‘‘Confidential
genomic sampling and of managing Submissions,’’ publicly viewable at
II. Paperwork Reduction Act of 1995 http://www.regulations.gov or at the
genomic data in clinical studies.
This guidance refers to previously Division of Dockets Management
DATES: Although you can comment on
approved collections of information between 9 a.m. and 4 p.m., Monday
any guidance at any time (see 21 CFR through Friday.
found in FDA regulations. These
10.115 (g)(5)), to ensure that the Agency • Confidential Submissions—To
collections of information are subject to
considers your comment on this draft submit a comment with confidential
review by the Office of Management and
guidance before it begins work on the information that you do not wish to be
Budget (OMB) under the Paperwork
final version of the guidance, submit made publicly available, submit your
Reduction Act of 1995 (44 U.S.C. 3501–
either electronic or written comments comments only as a written/paper
3520). The collections of information in
on the draft guidance by August 2, 2016. submission. You should submit two
21 CFR 312.8 and 312.320 have been
approved under OMB control number ADDRESSES: You may submit comments copies total. One copy will include the
0910–0014. as follows: information you claim to be confidential
Electronic Submissions with a heading or cover note that states
III. Electronic Access ‘‘THIS DOCUMENT CONTAINS
Persons with access to the Internet Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
may obtain the document at http://www. following way: Agency will review this copy, including
fda.gov/RegulatoryInformation/ • Federal eRulemaking Portal: http:// the claimed confidential information, in
Guidances/default.htm, http://www.fda. www.regulations.gov. Follow the its consideration of comments. The
gov/BiologicsBloodVaccines/Guidance instructions for submitting comments. second copy, which will have the
ComplianceRegulatoryInformation/ Comments submitted electronically, claimed confidential information
Guidances/default.htm, or http:// including attachments, to http:// redacted/blacked out, will be available
www.regulations.gov. www.regulations.gov will be posted to for public viewing and posted on http://
the docket unchanged. Because your www.regulations.gov. Submit both
Dated: May 31, 2016.
comment will be made public, you are copies to the Division of Dockets
Leslie Kux,
solely responsible for ensuring that your Management. If you do not wish your
Associate Commissioner for Policy. comment does not include any name and contact information to be
[FR Doc. 2016–13166 Filed 6–2–16; 8:45 am] confidential information that you or a made publicly available, you can
BILLING CODE 4164–01–P third party may not wish to be posted, provide this information on the cover
such as medical information, your or sheet and not in the body of your
anyone else’s Social Security number, or comments and you must identify this
DEPARTMENT OF HEALTH AND confidential business information, such information as ‘‘confidential.’’ Any
HUMAN SERVICES as a manufacturing process. Please note information marked as ‘‘confidential’’
Food and Drug Administration that if you include your name, contact will not be disclosed except in
information, or other information that accordance with 21 CFR 10.20 and other
[Docket No. FDA–2016–D–1255] identifies you in the body of your applicable disclosure law. For more
comments, that information will be information about FDA’s posting of
E18 Genomic Sampling and posted on http://www.regulations.gov. comments to public dockets, see 80 FR
Management of Genomic Data; • If you want to submit a comment 56469, September 18, 2015, or access
International Council for with confidential information that you the information at: http://www.fda.gov/
Harmonisation; Draft Guidance for do not wish to be made available to the regulatoryinformation/dockets/
Industry; Availability default.htm.
mstockstill on DSK3G9T082PROD with NOTICES
public, submit the comment as a
AGENCY: Food and Drug Administration, written/paper submission and in the Docket: For access to the docket to
HHS. manner detailed (see ‘‘Written/Paper read background documents or the
ACTION: Notice of availability. Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
received, go to http://
SUMMARY: The Food and Drug Written/Paper Submissions www.regulations.gov and insert the
Administration (FDA or Agency) is Submit written/paper submissions as docket number, found in brackets in the
announcing the availability of a draft follows: heading of this document, into the
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Document Created: 2018-02-08 07:29:51
Document Modified: 2018-02-08 07:29:51
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| 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. | |
| FR Citation | 81 FR 35779 |
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