[Federal Register Volume 85, Number 2 (Friday, January 3, 2020)]
[Notices]
[Pages 320-322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28408]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-3535]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Special Protocol Assessment; Guidance for Industry

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection in 
the April 2018 guidance for industry entitled ``Special Protocol 
Assessment'' (Revision 1).

DATES: Submit either electronic or written comments on the collection 
of information by March 3, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before March 3, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of March 3, 2020. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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. 
2016-N-3535 for ``Special Protocol Assessment; Guidance for Industry.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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

[[Page 321]]

``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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Special Protocol Assessment

OMB Control Number 0910-0470--Extension

    This information collection approval request is for the 2018 FDA 
guidance for industry, ``Special Protocol Assessment'' (Revision 1) (83 
FR 16367, April 16, 2018), that describes Agency procedures to evaluate 
issues related to the adequacy (e.g., design, conduct, analysis) of 
certain proposed studies. A copy of the guidance is available from our 
website at https://www.fda.gov/RegulatoryInformation/Guidances/default.htm. The guidance describes procedures for sponsors to request 
special protocol assessment and for FDA to act on such requests. The 
guidance provides information on how FDA interprets and applies 
provisions of the Food and Drug Administration Modernization Act of 
1997 and the specific Prescription Drug User Fee Act of 1992 (PDUFA) 
goals for special protocol assessment associated with the development 
and review of PDUFA products. The guidance describes the following two 
collections of information: (1) The submission of a notice of intent to 
request special protocol assessment of a carcinogenicity protocol; and 
(2) the submission of a request for special protocol assessment.

I. Notification for a Carcinogenicity Protocol

    As described in the guidance, a sponsor interested in an FDA 
assessment of a carcinogenicity protocol should notify the appropriate 
division in FDA's Center for Drug Evaluation and Research (CDER) or the 
Center for Biologics Evaluation and Research (CBER) of an intent to 
request special protocol assessment at least 30 days prior to 
submitting the request. With such notification, the sponsor should 
submit relevant background information so that FDA may review reference 
material related to carcinogenicity protocol design before receiving 
the carcinogenicity protocol.

II. Request for Special Protocol Assessment

    The guidance asks that a request for special protocol assessment be 
submitted as an amendment to the investigational new drug application 
(IND) for the underlying product and that it be submitted to FDA in 
triplicate with Form FDA 1571 (https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083533.pdf) attached. The guidance also 
suggests that the sponsor submit the cover letter to a request for 
special protocol assessment via fax to the appropriate division in CDER 
or CBER. FDA regulations (21 CFR 312.23(d)) state that information 
provided to us as part of an IND is to be submitted in triplicate and 
with the appropriate cover form, Form FDA 1571. An IND is submitted to 
FDA under existing regulations in part 312 (21 CFR part 312), which 
specifies the information that manufacturers must submit so that FDA 
may properly evaluate the safety and effectiveness of investigational 
drugs and biological products. The information collection requirements 
resulting from the preparation and submission of an IND under part 312 
have been estimated by FDA, and the reporting and recordkeeping burden 
has been approved by OMB under OMB control number 0910-0014.
    FDA suggests that the cover letter to the request for special 
protocol assessment be submitted via fax to the appropriate division in 
CDER or CBER to enable FDA staff to prepare for the arrival of the 
protocol for assessment. FDA recommends that a request for special 
protocol assessment be submitted as an amendment to an IND for two 
reasons: (1) To ensure that each request is kept in the administrative 
file with the entire IND and (2) to ensure that pertinent information 
about the request is entered into the appropriate tracking databases. 
Use of the information in FDA's tracking databases enables the 
appropriate Agency official to monitor progress on the evaluation of 
the protocol and to ensure that appropriate steps will be taken in a 
timely manner.
    The guidance recommends that the following information should be 
submitted to the appropriate Center with each request for special 
protocol assessment so that the Center may quickly and efficiently 
respond to the request:
     Questions to FDA concerning specific issues regarding the 
protocol.
     All data, assumptions, and information needed to permit an 
adequate evaluation of the protocol, including: (1) The role of the 
study in the overall development of the drug; (2) information 
supporting the proposed trial, including power calculations, the choice 
of study endpoints, and other critical design features; (3) regulatory 
outcomes that could be supported by the results of the study; (4) final 
labeling that could be supported by the results of the study; and (5) 
for a stability

[[Page 322]]

protocol, product characterization and relevant manufacturing data.
    Description of Respondents: A sponsor, applicant, or manufacturer 
of a drug or biologic product that FDA regulates under the Federal 
Food, Drug, and Cosmetic Act or section 351 of the Public Health 
Service Act (42 U.S.C. 262) requesting special protocol assessment.
    Burden Estimate: Table 1 provides an estimate of the annual 
reporting burden for notifications for a carcinogenicity protocol and 
requests for a special protocol assessment.
    Notification for a Carcinogenicity Protocol: Based on the number of 
notifications for carcinogenicity protocols and the number of 
carcinogenicity protocols currently submitted to CDER and CBER, CDER 
estimates that it will receive approximately 188 notifications of an 
intent to request special protocol assessment of a carcinogenicity 
protocol per year from approximately 105 sponsors. CBER estimates that 
it will receive approximately one notification of an intent to request 
special protocol assessment of a carcinogenicity protocol per year from 
approximately one sponsor. The hours per response, which is the 
estimated number of hours that a sponsor would spend preparing the 
notification and background information to be submitted in accordance 
with the guidance, is estimated to be approximately 8 hours.
    Requests for Special Protocol Assessment: Based on the number of 
requests for special protocol assessment currently submitted to CDER 
and CBER, CDER estimates that it will receive approximately 108 
requests for special protocol assessment per year from approximately 
105 sponsors. CBER estimates that it will receive approximately eight 
requests from approximately eight sponsors. The hours per response is 
the estimated number of hours that a respondent would spend preparing 
the information to be submitted with a request for special protocol 
assessment, including the time it takes to gather and copy questions to 
be posed to the Agency regarding the protocol and data, assumptions, 
and information needed to permit an adequate evaluation of the 
protocol. Based on our experience with these submissions, we estimate 
approximately 15 hours on average would be needed per response.

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
 Information collection activity     Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Notification for Carcinogenicity             106            1.78             189               8           1,510
 Protocols......................
Requests for Special Protocol                113            1.66             116              15           1,740
 Assessment Reports.............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............             305  ..............           3,250
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The information collection reflects an adjustment in burden by 608 
hours. We attribute this adjustment to an increase in the number of 
submissions we received over the last few years.

    Dated: December 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-28408 Filed 1-2-20; 8:45 am]
 BILLING CODE 4164-01-P