[Federal Register Volume 82, Number 215 (Wednesday, November 8, 2017)]
[Pages 51846-51847]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24296]



Food and Drug Administration

[Docket No. FDA-2013-D-0575]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry on Expedited Programs for 
Serious Conditions--Drugs and Biologics

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed revision of an existing collection of information, and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on the information collection in the guidance for 
industry ``Expedited Programs for Serious Conditions--Drugs and 

DATES: Submit either electronic or written comments on the collection 
of information by January 8, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 8, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of January 8, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-D-0575 for ``Guidance for Industry on Expedited Programs for 
Serious Conditions--Drugs and Biologics.'' Received comments, those 
filed in a timely manner (see ADDRESSES), will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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].


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

OMB Control Number 0910-0765--Revision

    This information collection supports the previous captioned Agency 
guidance. The guidance provides a single resource for information on 
FDA's policies and procedures related to the following expedited 
programs for serious conditions: (1) Fast track designation, (2) 
breakthrough therapy designation, (3) accelerated approval, and (4) 
priority review designation. The guidance describes threshold criteria 
generally applicable to expedited programs, including what is meant by 
serious condition, unmet medical need, and available therapy. The 
guidance addresses the applicability of expedited programs to rare 
diseases, clarification on available therapy, and additional detail on 
possible flexibility in manufacturing and product quality. The guidance 
also clarifies the qualifying criteria for breakthrough therapy

[[Page 51847]]

designation and provides examples of surrogate endpoints and 
intermediate clinical endpoints used to support accelerated approval.
    The information collection resulting from requests for priority 
review designation and breakthrough therapy designation is set forth in 
rows 1 and 2 of table 1 and is approved by the Office of Management and 
Budget (OMB) under control number 0910-0765. The information collection 
resulting from requests for accelerated approval is approved by OMB 
under control numbers 0910-0001 and 0910-0338.
    The provisions of the guidance relating to fast track development 
and other issues such as serious condition and unmet medical need 
replace the guidance entitled ``Fast Track Drug Development Programs--
Designation, Development, and Application Review.'' Consequently, the 
information collection resulting from the guidance ``Fast Track Drug 
Development Programs--Designation, Development, and Application 
Review'' (OMB control number 0910-0389) is now being incorporated into 
OMB control number 0910-0765 (guidance for industry ``Expedited 
Programs for Serious Conditions--Drugs and Biologics'').
    A sponsor or applicant who seeks fast track designation is required 
to submit a request to the Agency showing that the drug product: (1) Is 
intended for a serious or life-threatening condition and (2) has the 
potential to address an unmet medical need. The Agency expects that 
most information to support a designation request will have been 
gathered under existing requirements for preparing an investigational 
new drug (IND), new drug application (NDA), or biologic license 
application (BLA). If such information has already been submitted to 
the Agency, the information may be summarized in the fast track 
designation request. A designation request should include, where 
applicable, additional information not specified elsewhere by statute 
or regulation. For example, additional information may be needed to 
show that a product has the potential to address an unmet medical need 
where an approved therapy exists for the serious or life-threatening 
condition to be treated. Such information may include clinical data, 
published reports, summaries of data and reports, and a list of 
references. The amount of information and discussion in a designation 
request need not be voluminous, but it should be sufficient to permit a 
reviewer to assess whether the criteria for fast track designation have 
been met.
    After the Agency makes a fast track designation, a sponsor or 
applicant may submit a premeeting package that 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. 
As with the request for fast track designation, the Agency expects that 
most sponsors or applicants will have gathered such information to meet 
existing requirements for preparing an IND, NDA, or BLA. These may 
include descriptions of clinical safety and efficacy trials not 
conducted under an IND (e.g., foreign studies) and information to 
support a request for accelerated approval. If such information has 
already been submitted to FDA, the information may be summarized in the 
premeeting package.
    The Agency estimates the total annual number of respondents 
submitting requests for fast track designation is approximately 140, 
and the number of requests received is approximately 187 annually. FDA 
estimates that the number of hours needed to prepare a request for fast 
track designation is approximately 60 hours per request (row 3 in table 
    Of the requests for fast track designation made per year, the 
Agency granted approximately 132 requests from 107 respondents, and for 
each of these granted requests, a premeeting package was submitted to 
the Agency. FDA estimates that the preparation hours are approximately 
100 hours per premeeting package (row 4 in table 1).
    The guidance also refers to previously approved collections of 
information found in FDA regulations. The collections of information in 
21 CFR 202.1 and 21 CFR parts 314, and 601, and sections 505(a), 
506(a)(1), 735, and 736 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(a), 356(a)(1), 379(g), and 379(h)) have been approved under 
OMB control numbers 0910-0686, 0910-0001, 0910-0338, 0910-0014, and 
    FDA estimates the burden of this collection of information as 

                                  Table 1--Estimated Annual Reporting Burden 1
Guidance for Industry: Expedited                     Number of                        Average
Programs for Serious Conditions--    Number of     responses per   Total annual     burden per      Total hours
       Drugs and Biologics          respondents     respondent       responses       response
Priority review designation                   48             1.7              82              30           2,400
Breakthrough therapy designation              87            1.29             113              70           7,910
Fast track designation request..             140            1.33             187              60          11,220
Fast track 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

    The data pertaining to fast track designation (last two rows of 
table 1) has changed since the last OMB approval.

    Dated: November 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24296 Filed 11-7-17; 8:45 am]