Right to Try Reporting Requirements SSA NEW 2020

UNITED STATES FOOD & DRUG ADMINISTRATION
Right to Try Act of 2017:
Reporting Requirements
OMB Control No. 0910-NEW

SUPPORTING STATEMENT Part A – Justification:

1. Circumstances Making the Collection of Information Necessary
This information collection supports proposed rulemaking intended to implement The
Right to Try Act of 2017. The Right to Try Act amended Chapter V of the Federal Food
Drug and Cosmetic Act (FD&C Act) by adding section 561B (21 U.S.C. 360bbb-0), which
provides for the submission of an annual summary of the use of eligible investigational
drug by sponsors or manufacturers (21 U.S.C. 360bbb-0a). The proposed rule would add
subpart D to our regulations in 21 CFR part 300 pertaining to general drug provisions.
Under Right to Try, patients may request and sponsors or manufacturers may elect to
provide, access to certain unapproved, investigational drugs and biological products for
patients diagnosed with life-threatening diseases or conditions who have exhausted
approved treatment options and who are unable to participate in a clinical trial involving
the investigational drug. This includes an investigational drug or biological product:
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for which a Phase 1 clinical trial has been completed (section 561B(a)(2)(A));
that has not been approved or licensed for any use by the FDA (section
561B(a)(2)(B));
for which an application has been filed with the FDA or is under investigation in a
clinical trial that is intended to form the primary basis of a claim of effectiveness in
support of FDA approval or licensure and is the subject of an active investigational
new drug application submitted to the FDA (section 561B(a)(2)(C)); and
whose active development or production is ongoing, and that has not been
discontinued by the manufacturer or placed on clinical hold by the FDA (section
561B(a)(2)D)).

We therefore request OMB approval for the information collection provisions set forth in
our proposed rulemaking establishing reporting requirements under 21 CFR part 300,
subpart D.
2. Purpose and Use of the Information Collection
We are taking this action to provide a pathway for eligible patients to request access to
investigational drugs under certain conditions, as governed by section 561B.

3. Use of Improved Information Technology and Burden Reduction
Because associated regulations require the electronic submission of information, we expect
100% of respondents will utilize electronic means to satisfy the reporting requirements.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. The proposed rule would add new
subpart D to 21 CFR part 300 to specify the deadline and content for submission of an
annual summary of use under section 561B of the FD&C Act.
5. Impact on Small Businesses or Other Small Entities
No small businesses will be impacted by the information collection.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with current statutory and proposed
regulatory requirements.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
As required by section 44. U.S.C. 3506(c)(2)(B), we invited public comment on the
proposed collection of information in the Federal Register of July 24, 2020 (85 FR 44803).
9. Explanation of Any Payment or Gift to Respondents
No remuneration is provided to respondents to the information collection.
10. Assurance of Confidentiality Provided to Respondents
Although patient information is provided to determine criteria for eligibility, no personally
identifiable information (PII) is used as a means of retrieval for the information collection,
nor is this element included as part of respondent submissions. At the same time, we have
consulted our Privacy Office and are conducting a comprehensive assessment under The
Privacy Act of 1974.

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11. Justification for Sensitive Questions
There are no questions of a sensitive nature associated with the information collection.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
The proposed rule would establish requirements for the deadline and content of an annual
summary for sponsors and manufacturers who provide an eligible investigational drug for
use by an eligible patient. We estimate that 6 sponsors and manufacturers would prepare
and submit 1 annual summary and that it would take approximately 2.5 hours to prepare
and submit each report. Our estimate is based on data and information discussed in
Section VI. Preliminary Economic Analysis of Impacts of this document.
21 CFR Citation;
Type of Activity

Table 1.--Estimated Annual Reporting Burden
No. of
No. of
Total
Respondents
Responses per
Annual
Respondent
Responses

300.200; annual summaries
from sponsors and
manufacturers under the
Right to Try Act

6

1

6

Average
Burden per
Response

Total
Hours

2.5 (150
minutes)

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12b. Annualized Cost Burden Estimate
We calculate labor costs with the estimated 15 reporting hours described above. As
discussed in Section VI. of our Preliminary Economic Analysis of Impacts, we estimate
costs as the time sponsors and manufacturers would prepare and submit annual summaries
based on eligible patients’ requests for investigational new treatments. Assuming a fullyloaded industry wage rate of approximately $212.78 per hour, we estimate these costs as
approximately $3,191.70
Table 2. – Estimated Annual Cost Burden
Total Burden
Hourly Wage
Hours
Rate
Medical and Health Services Managers in
15
$212.78
the Pharmaceutical and Medicine
Manufacturing average wage grade for
preparing and submitting this information
collection
Type of Respondent

Total Respondent Costs
$3,191.70

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start-up, or operating or maintenance costs associated with this
information collection.

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14. Annualized Cost to the Federal Government
Our estimated cost to the Federal Government reflects the allocation of 1 full-time
employee who will review the annual summaries sent to FDA under 21 CFR 300, subpart
D and assist the FDA web team with posting annual summaries on our website. Using a
fully-loaded wage, meaning both salary and non-wage benefits, per employee for the
Washington DC-Metropolitan area found at www.opm.gov, we calculate an annual cost of
$284,299 for a GS-13-5.
15. Explanation for Program Changes or Adjustments
This is a new information collection.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no publications or other schedules.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA will display the OMB expiration date as required by 5 CFR 1320.5.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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