Document ID: FDA-2019-N-5553-0025
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Annual Summary Reporting Requirements Under the Right to Try Act
Posted Date: 2022-10-24T04:00Z

[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Notices]
[Pages 64226-64227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23035]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5553]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Annual Summary 
Reporting Requirements Under the Right to Try Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) 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 by November 23, 2022.

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 0910-0893. 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.

Annual Summary Reporting Requirements Under the Right to Try Act

OMB Control Number 0910-0893

    This information collection helps to implement provisions of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act), added by the Right to 
Try Act, which requires sponsors and manufacturers who provide an 
``eligible investigational drug'' under the Right to Try Act to submit 
to FDA an annual summary of such use. Regulations under Sec.  300.200 
(21 CFR 300.200) will require that sponsors and manufacturers submit to 
FDA an annual summary no later than March 31 of each year, including 
data for the preceding calendar year, that includes the following data 
elements:
     The name of the eligible investigational drug and 
applicable investigational new drug application number.
     The number of doses supplied to the eligible patient.
     The number of eligible patients treated.
     The use for which the eligible investigational drug was 
made available to the eligible patient.
     Any known serious adverse events and outcomes that the 
eligible patient treated with an eligible investigational drug 
experienced.
    Description of Respondents: Respondents to the information 
collection are sponsors and manufacturers who provide an eligible 
investigational drug to eligible patients in accordance with the Right 
to Try Act and will submit to FDA annual summaries.
    In the Federal Register of September 14, 2022 (87 FR 56269), we 
published a final rule (RIN 0910-AI36), including an analysis of the 
information collection, and discussed the development of an associated 
form to facilitate submission of the requisite information. 
Accordingly, we have developed Form FDA 5023 entitled ``Right To Try 
Reporting Requirement: Annual Summary,'' which is currently available 
in the docket for comment purposes only, and we are inviting public 
comment. As required by the applicable statute, section 561B of the 
FD&C Act (21 U.S.C. 360bbb-0a), the information is submitted to an FDA-
designated point of contact, and in accordance with instructions to be 
posted at: https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try.
    We estimate the burden of this collection of information as 
follows:

[[Page 64227]]

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of                       Average burden
                     Activity; 21 CFR citation                          Number of      responses per     Total annual     per response     Total hours
                                                                       respondents       respondent       responses        (in hours)
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Sponsors and manufacturers submit annual summaries in accordance                  6                1                6              2.5               15
 with the Right to Try Act (Sec.   300.200) using Form FDA 5023....
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Consistent with estimates in our Final Regulatory Impact Analysis 
for the associated final rule, we estimate that six sponsors and 
manufacturers will prepare and submit Form FDA 5023 and assume it takes 
2.5 hours to prepare and submit each summary, which results in a total 
of 15 hours annually.

    Dated: October 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23035 Filed 10-21-22; 8:45 am]
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