81 FR 26799 - Special Protocol Assessment; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 86 (May 4, 2016)

Page Range		26799-26800
FR Document		2016-10391

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Special Protocol Assessment.'' This draft guidance provides information about the procedures and general policies adopted by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for special protocol assessment (SPA). This draft guidance is intended to improve the quality of Requests for SPAs and accompanying submission materials, and the quality of the resulting interaction between sponsors and FDA. This draft guidance revises the guidance for industry entitled ``Special Protocol Assessment'' issued May 17, 2002.

Federal Register, Volume 81 Issue 86 (Wednesday, May 4, 2016)

[Federal Register Volume 81, Number 86 (Wednesday, May 4, 2016)]
[Notices]
[Pages 26799-26800]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-10391]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1174]

Special Protocol Assessment; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Special
Protocol Assessment.'' This draft guidance provides information about
the procedures and general policies adopted by the Center for Drug
Evaluation and Research (CDER) and the Center for Biologics Evaluation
and Research (CBER) for special protocol assessment (SPA). This draft
guidance is intended to improve the quality of Requests for SPAs and
accompanying submission materials, and the quality of the resulting
interaction between sponsors and FDA. This draft guidance revises the
guidance for industry entitled ``Special Protocol Assessment'' issued
May 17, 2002.

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draft guidance before it begins work on the final version of the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 5, 2016.

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 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-2016-D-1174 for ``Special Protocol Assessment; Draft 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

[[Page 26800]]

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 the draft 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
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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Amalia Himaya, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6439, Silver Spring, MD 20993-0002, 301-
796-0700; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 3128, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry
entitled ``Special Protocol Assessment.'' SPA is a process by which
sponsors may request to meet with FDA to reach agreement on the design
and size of certain trials, clinical studies, or animal trials to
determine if they adequately address scientific and regulatory
requirements. After completing the SPA review, FDA issues a letter
including an assessment of the protocol, agreement or nonagreement with
the proposed protocol, and answers to the sponsor's relevant questions.
Section 119 of the Food and Drug Administration Modernization Act of
1997 amended section 505(b) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 355(b)) and directed FDA to meet with
sponsors who request to meet, provided certain conditions are met, to
reach agreement on the design and size of the well-controlled clinical
trials intended to form the primary basis for a demonstration of
effectiveness in a marketing application submitted under section 505(b)
of the FD&C Act or section 351 of the Public Health Service (PHS) Act
(42 U.S.C. 262). These provisions subsequently were amended in section
7002(d)(1) of the Biologics Price Competition and Innovation Act of
2009 to include any necessary clinical study or studies for biosimilar
biological product applications under section 351(k) of the PHS Act. In
2013, the Pandemic and All Hazards Preparedness Reauthorization Act of
2013 (Pub. L. 113-5) further amended the SPA provisions to provide for
SPA agreements regarding animal and associated clinical trials
conducted in support of applications for products developed under 21
CFR part 314 subpart I, and 21 CFR part 601 subpart H (the animal
rule). Such marketing applications include new drug applications
(NDAs), biologics license applications (BLAs), and efficacy supplements
to approved NDAs and BLAs.
In conjunction with the Prescription Drug User Fee Amendments of
2012 (PDUFA V), enacted as part of the Food and Drug Administration
Safety and Innovation Act (FDASIA), and with the Biosimilar User Fee
Act of 2012 (BsUFA), enacted as part of FDASIA, FDA agreed to specific
performance goals (PDUFA V goals and BsUFA goals, respectively) for
SPA. Per section 505(b)(5)(B) of the FD&C Act, the PDUFA V goals, and
the BsUFA goals, the following protocols are eligible for SPA: (1)
Animal carcinogenicity protocols; (2) drug substance and drug product
stability protocols; (3) animal efficacy protocols for studies intended
to provide primary evidence of effectiveness required for approval or
for licensure for products developed under the animal rule; (4)
protocols for clinical trials or studies intended to form the primary
basis of an efficacy claim; and (5) protocols for clinical studies
necessary to prove biosimilarity and/or interchangeability.
This draft guidance revises the guidance of the same name issued in
May 2002. After it has been finalized, this guidance will replace the
May 2002 guidance. Significant changes from the 2002 version include
the following: (1) Clarifying which protocols are eligible for SPA; (2)
adding animal rule efficacy protocols intended to support approval
under part 314 subpart I, and part 601 subpart H, for drugs and
biological products, respectively; (3) adding protocols intended to
support approval of a biosimilar biological product; (4) providing
greater detail about the content of an SPA submission; and (5)
clarifying the process for rescinding an SPA agreement. FDA seeks
comments to aid in finalizing this draft guidance.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the procedural
aspects of SPA. 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. The Paperwork Reduction Act of 1995

This draft guidance refers to previously approved collections of
information that 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 referred to in the guidance
entitled ``Special Protocol Assessment'' have been approved under OMB
control number 0910-0470. The collections of information for FDA Form
1571 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/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

Dated: April 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10391 Filed 5-3-16; 8:45 am]
BILLING CODE 4164-01-P

Document Created: 2016-05-04 01:23:12
Document Modified: 2016-05-04 01:23:12

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.
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 5, 2016.
Contact		Amalia Himaya, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6439, Silver Spring, MD 20993-0002, 301- 796-0700; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, 240-402-7911.
FR Citation		81 FR 26799

81 FR 26799 - Special Protocol Assessment; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 86 (May 4, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration