0389 and 0765 SSA consolidation 2018

U.S. Food and Drug Administration
Guidance for Industry Fast Track Drug Development Programs —
Designation, Development, and Application Review
OMB Control Nos. 0910-0389 and 0910-0765
SUPPORTING STATEMENT Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA) guidance. Under
Section 506 of the Federal Food, Drug, and Cosmetic Act (FFDCA or the act)(21 U.S.C. 356),
FDA is authorized to take appropriate action to facilitate the development and expedite the
review of new drugs, including biological products, intended to treat a serious or life-threatening
condition and that demonstrate a potential to address an unmet medical need. Accordingly, FDA
has issued the guidance document entitled “Guidance for Industry on Expedited Programs for
Serious Conditions – Drugs and Biologics,” currently approved under OMB Control No. 09100765. The guidance provides a single resource for information on FDA policies and procedures
related to expedited review programs for serious conditions and is intended to facilitate and
expedite development and review of new drugs and biologics1 to address unmet medical needs in
the treatment of serious and life-threatening conditions. This guidance includes the following
programs:
Fast track designation – explains that all manufacturers of drug and biological drug
products seeking to have a product or indication designated for fast track drug development
under section 506 of the FFDCA submit a request for fast track designation as an amendment to
an investigational new drug application (IND) or as a supplement to a drug or biologic marketing
application. After FDA makes a fast track designation, a sponsor or applicant may submit a
premeeting package, which may include additional information supporting a request to
participate in certain fast track programs. The premeeting package serves as background
information for the meeting and should support the intended objectives of the meeting. The
agency expects that most sponsors or applicants will have already gathered such information to
meet existing requirements for fast track designation or meetings under the FFDCA, the Public
Health Service Act, or implementing regulations.
Priority Review Designation Request – explains that a sponsor may expressly request
priority review of a marketing application. Under the Prescription Drug User Fee Act (PDUFA),
FDA agreed to specific goals for improving the drug review time and created a two tiered system
of review times – standard review and priority review. A priority review means that the time it
takes FDA to review a marketing application is reduced.
Breakthrough Therapy Designation Request – describes the process for applicants to
request breakthrough therapy designation. Section 506(a) of the FFDCA, as added by section
902 of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 provides
1

For this GFI, all references to new drugs or drug products include both human drugs and biological products
regulated by CDER and CBER.

for the designation of a drug as a breakthrough therapy if it meets the qualifying criteria. Section
902 of FDASIA instructs FDA to take actions appropriate to expedite the development and
review of a breakthrough therapy.
Accelerated Approval – describes the qualifying criteria, relevant terms and the
conditions of the accelerated approval pathway. Under section 506(c) of the FFDCA, a product
for a serious or life-threatening disease or condition may be granted accelerated approval if FDA
determines that the product has an effect on a surrogate endpoint that is reasonably likely to
predict clinical benefit or on a clinical endpoint that can be measured earlier than irreversible
morbidity or mortality (IMM) or other clinical benefit. Products granted approval under the
accelerated approval pathway, require postmarketing confirmatory trials to verify and describe
the anticipated effect on IMM or other clinical benefit. This approval pathway is used primarily
in settings in which the disease course is long and an extended period of time is required to
measure the intended benefit of treatment and there are few, if any, alternatives for treatment.
As discussed in our 60- and 30- day Federal Register notices, and because the previously
separate information collection elements are now addressed in a single agency guidance, we are
requesting consolidation of OMB Control No. 0910-0389 into 0910-0765. Upon OMB approval
of this request, FDA will discontinue collection 0910-0389.
2. Purpose and Use of the Information Collection
FDA uses the information to determine whether a particular drug or biological product should be
designated as a drug in a fast track drug development program and whether a drug or biological
product so designated continues to meet the criteria for fast track designation.
3. Use of Improved Information Technology and Burden Reduction
To improve the use of information technology in the submission of marketing applications for
human drugs and related reports, FDA has developed and issued guidances for industry on
electronic submissions. These guidance documents are available on FDA's Web
site at: http://www.fda.gov/drugs/GuidanceComplianceRegulatoryInformation/Guidances/
default.htm.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. Respondents should note that information
collection provisions related to accelerated approval of applications for drugs and biologics are
currently approved under OMB Control Nos. 0910-0001 and 0338 respectively, and that while
the subject guidance document references information collection found in existing agency
regulations and approved under separate ICRs (e.g., OMB Control Nos. 0910-0001; 0297; and
0686), this information collection supports those recommendations found in the guidance that
may pose additional burden not already covered by other collections. Those collection elements
are discussed in this supporting statement more fully above and in detail throughout the guidance
document, available at: https://www.fda.gov/downloads/Drugs/Guidances/UCM358301.pdf

2

5. Impact on Small Businesses or Other Small Entities
While FDA cannot apply different standards with respect to statutory requirements, we do
provide help to small businesses. The Center for Biologics Evaluation and Research, Office of
Communications, Training, and Manufacturers Assistance and the Center for Drug Evaluation
and Research, Office of Communications provide assistance to small businesses subject to FDA's
regulatory requirements. In addition, FDA provides guidance for small business on its website at
www.fda.gov.
6. Consequences of Collecting the Information Less Frequently
Information collection is consistent with applicable statutory requirements and existing
regulations, and determined by respondents who wish to submit information to FDA consistent
with guidance recommendations. There are no technical obstacles to reducing the burden.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
An applicant may be required to submit to FDA proprietary trade secrets or other confidential
information when submitting a drug or biological product license application or supplement.
FDA has instituted security measures to protect confidential information received from
manufacturers and will, to the extent permitted by law, protect this information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8 (d), FDA published a 60-day notice for comment in the Federal
Register of November 8, 2017 (82 FR 51847). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
No payment or gift is provided to respondents.
10. Assurance of Confidentiality Provided to Respondents
The confidentiality of information received by FDA under the guidance would be consistent with
the Freedom of Information Act (FOIA) and the FDA's regulations under 21 CFR Part 20.
Manufacturers seeking to market a drug or biological product in interstate commerce may be
required to include proprietary or trade information in an application submitted for FDA approval.
However, such proprietary or trade information is deleted from any information released by FDA
under FOIA and FDA regulations.
11. Justification for Sensitive Questions
Questions of a sensitive nature are not applicable to this information collection.

3

12. Estimates of Annualized Burden Hours and Costs
We estimate the burden for the information collection as follows:
12a. Annualized Hour Burden Estimate
As reflected in Table 1 below, we estimate 48 applicants will prepare and submit a total
of approximately 82 priority review designation submissions in accordance with
recommendations found in the guidance, and that the added burden for each submission will be
approximately 30 hours to develop and submit to FDA as part of the application. We further
estimate 87 applicants will prepare a total of approximately 113 breakthrough therapy
designation submissions in accordance with the guidance and that the added burden for each
submission will be approximately 70 hours to prepare and submit.
We also estimate that in accordance with the guidance, approximately 187 requests for
fast track designation will be received from approximately 140 applicants. Of these applicants,
107 will also submit approximately 132 fast track premeeting packages. Each designation
request adds 60 hours of added information collection burden to prepare and submit it as part of
the review application. Premeeting packages require approximately 100 hours information
collection burden per request.
Table 1-- Estimated Annual Reporting Burden1
Guidance for Industry:
No. of
No of
Total
Average
Total Hours
Expedited programs for
Respondents
Responses
Annual
Burden per
serious conditions – Drugs
per
Responses
Response
and Biologics
Respondent
Priority review designation
48
1.7
82
30
2,400
request
Breakthrough therapy
87
1.29
113
70
7,910
designation request
Designation Requests
140
1.33
187
60
11,220
Premeeting Packages
107
1.23
132
100
13,200
TOTAL
34,730
1
There are no capital costs or operating and maintenance costs associated with this collection of information.

12b. Annualized Cost Burden Estimate
We assume labor costs for priority review, breakthrough therapy, and fast track designation
requests based on an average pharmaceutical industry loaded wage rate of $85.00 per hour for
developing and submitting the requests. Multiplied by the total hour burdens estimated above, the
total cost burden to respondents for these expedited programs for serious conditions is estimated
as $2,952,050.
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start up, operating or maintenance costs associated with this information
collection.

4

14. Annualized Cost to the Federal Government
We estimate that costs of the information collection are absorbed through existing resource
allocations.
15. Explanation for Program Changes or Adjustments
The information collection reflects both agency adjustments and revision. There is an adjustment
of 24,420 burden hours and 321 annual responses for an overall increase. This is attributable to an
increase in submissions. Also, and as discussed previously in this supporting statement and
included in the burden table under Question 12, we have revised the collection to consolidate
burden from the two IC elements previously captured under OMB Control No. 0910-0389.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no tabulated results to publish for this information collection.
17. Reason(s) Display of OMB Expiration Date Is Inappropriate
FDA is not seeking approval to exempt the display of the expiration date of the OMB approval.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

5