[Federal Register Volume 85, Number 65 (Friday, April 3, 2020)]
[Notices]
[Pages 18991-18992]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06983]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Special Protocol 
Assessment; Guidance for Industry

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information May 4, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0470. Also include the FDA docket 
number found in brackets in the heading of this document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Special Protocol Assessment

OMB Control Number 0910-0470--Revision

    This information collection request supports Agency guidance 
entitled ``Special Protocol Assessment'' (Revision 1) (83 FR 16367, 
April 16, 2018), which describes procedures FDA uses 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 protocol, product characterization and relevant 
manufacturing data.
    Description of Respondents: A sponsor, applicant, or manufacturer 
of a drug or biologic product that FDA

[[Page 18992]]

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.
    In the Federal Register of January 3, 2020 (85 FR 320) we published 
a 60-day notice requesting public comment on the proposed collection of 
information. Although one comment was received, it was not responsive 
to the information collection topics solicited in the notice.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
 Information collection activity     Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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Notification for Carcinogenicity             106            1.78             189               8           1,510
 Protocols......................
Requests for Special Protocol                113            1.03             116              15           1,740
 Assessment Reports.............
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    Total.......................  ..............  ..............             305  ..............           3,250
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    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. 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: March 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06983 Filed 4-2-20; 8:45 am]
BILLING CODE 4164-01-P