[Federal Register Volume 82, Number 215 (Wednesday, November 8, 2017)]
[Notices]
[Pages 51846-51847]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24296]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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
Biologics.''
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
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
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].
SUPPLEMENTARY INFORMATION:
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
1).
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
0910-0297.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1
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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
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Priority review designation 48 1.7 82 30 2,400
request........................
Breakthrough therapy designation 87 1.29 113 70 7,910
request........................
Fast track designation request.. 140 1.33 187 60 11,220
Fast track premeeting packages.. 107 1.23 132 100 13,200
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Total....................... .............. .............. .............. .............. 34,730
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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]
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