Expedited Programs for Serious Conditions - Drugs and Biologics; Guidance for Industry

U.S. Food and Drug Administration
Expedited Programs for Serious Conditions - Drugs and Biologics;
Guidance for Industry
OMB Control No. 0910-0765
Non-substantive Change Request:
FDA is requesting a non-substantive change to OMB Control No. 0910-0765, which supports the
above-captioned agency guidance document. The guidance describes FDA policies and
procedures related to the following expedited review programs: Fast Track Designation;
Priority Review Designation Requests; Breakthrough Designation Requests; and Accelerated
Approval. In the Federal Register of November 17, 2017 (82 FR 54385), we announced the
availability of a draft guidance entitled “Expedited Programs for Regenerative Medicine
Therapies for Serious Conditions; Draft Guidance for Industry” (“RMAT draft guidance”). The
RMAT draft guidance explains an additional program referred to as “regenerative medicine
advanced therapy” (RMAT) designation and provides our current thinking on the expedited
development and review of these products.
Similar to the information collection found in the guidance document currently included in the
approved collection package, the information collection found in the RMAT draft guidance
document also supports the implementation of section 506(g) of the Federal Food, Drug, and
Cosmetic Act. Section 506(g) authorizes the agency 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. Both guidance documents also include recommendations and instruction on
information needed by FDA to make a determine as to whether a particular product satisfies
certain designation criteria. While the RMAT draft guidance discusses an additional expedited
program available to sponsors, we do not believe it introduces new information collection.
Rather, it informs sponsors of an additional alternative by which certain products may be
evaluated for a specified designation request. A sponsor may apply for and receive more than
one designation for a given product. At the same time, sponsors need to apply for each
designation separately. Also, the information a sponsor must submit in order to apply for RMAT
designation is substantially the same information that a sponsor must submit in order to apply for
the other designation requests, namely a request for the designation as well as a premeeting
package with supporting material.
As discussed above, we believe the information collection elements associated with RMAT
designations are reflected under OMB Control No. 0910-0765; however, we have considered that
additional respondents may be included to reflect those preparing and submitting RMAT
designation requests. Based on a review of agency data, we estimate that 35 applicants will
prepare and submit RMAT designation requests, and that each submission will require
approximately 60 hours to develop and submit to FDA as part of the application. We also
estimate that 10 premeeting packages will be prepared and that it will require approximately 100
hours per request. These estimates are reflected in the following table:

Table 1-- Estimated Annual Reporting Burden
Expedited programs for
serious conditions – Drugs
and Biologics

No. of
Respondents

RMAT Designation Requests
Premeeting Packages
TOTAL

35
10

No of
Responses
per
Respondent
1
1

Total
Annual
Responses

Average
Burden per
Response

Total Hours

35
10

60
100

2,100
1,000
3,100

We intend to finalize the RMAT draft guidance, and we believe it is appropriate to consolidate
the RMAT designation requests and premeeting packages with those approved under OMB
Control No. 0910-0765. We also propose to retitle the information collection: “Expedited
Programs for Serious Conditions - Drugs and Biologics” to reflect that it includes more than a
single FDA guidance document.
Dated: September 2018

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