83 FR 5428 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 26 (February 7, 2018)

Page Range		5428-5429
FR Document		2018-02415

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Federal Register, Volume 83 Issue 26 (Wednesday, February 7, 2018)

[Federal Register Volume 83, Number 26 (Wednesday, February 7, 2018)]
[Notices]
[Pages 5428-5429]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-02415]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by March
9, 2018.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0389.
Also include the FDA docket number found in brackets in the heading of
this document.

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,
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Guidance for Industry: ``Expedited Programs for Serious Conditions--
Drugs and Biologics''

OMB Control Numbers 0910-0389 and 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
designation and provides examples of surrogate endpoints and
intermediate clinical endpoints used to support accelerated approval.

[[Page 5429]]

In the Federal Register of November 8, 2017 (82 FR 51846), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. No comments were received.
We therefore estimate the burden of the information collection as
follows:

Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Guidance for industry: Expedited Number of Average
programs for serious Number of responses per Total annual burden per Total hours
conditions-- Drugs and biologics respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Priority review designation 48 1.7 82 30 2,400
request (0765).................
Breakthrough therapy designation 87 1.29 113 70 7,910
request (0765).................
Fast track designation request 140 1.33 187 60 11,220
(0389).........................
Fast track premeeting packages 107 1.23 132 100 13,200
(0389).........................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 34,730
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

The information collection elements regarding priority review
designation and breakthrough therapy designation requests are reflected
in rows 1 and 2 of table 1 and are currently approved under OMB control
number 0910-0765. Meanwhile, fast track designation requests and
premeeting packages are currently approved under OMB Control No. 0910-
0389. We are therefore revising OMB control number 0910-0389 to include
all four collection elements. Information collection burden for
accelerated approval requests is currently approved under OMB control
numbers 0910-0001 (drugs) and 0910-0338 (biologics). The estimates
provided are based on our experience with the respective collection
elements over the past 3 years.
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 biologics 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 total burden
hours for fast track designation and fast track meetings has increased
due to increased requests; however, the hours per request have remained
the same.

Dated: February 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02415 Filed 2-6-18; 8:45 am]
BILLING CODE 4164-01-P

5428 Federal Register / Vol. 83, No. 26 / Wednesday, February 7, 2018 / Notices

and associated materials (see Number: CMS–10453 (OMB control SUMMARY: The Food and Drug
ADDRESSES). number: 0938–1228); Frequency: On Administration (FDA) is announcing
CMS–10453 The Medicare Advantage occasion; Affected Public: Private sector that a proposed collection of
and Prescription Drug Program: Part C (Business or other for-profits); Number information has been submitted to the
Explanation of Benefits and of Respondents: 468; Number of Office of Management and Budget
Supporting Regulations Responses: 5,616; Total Annual Hours: (OMB) for review and clearance under
CMS–1856 Request for Certification in 74,880. (For policy questions regarding the Paperwork Reduction Act of 1995.
the Medicare/Medicaid Program for this collection contact Natalie Albright DATES: Fax written comments on the
Providers of Outpatient Physical at 410–786–1671.) collection of information by March 9,
Therapy and/or Speech-Language 2. Type of Information Collection 2018.
Pathology Request: Reinstatement of a previously ADDRESSES: To ensure that comments on
Under the PRA (44 U.S.C. 3501– approved collection; Title of the information collection are received,
3520), federal agencies must obtain Information Collection: Request for OMB recommends that written
approval from the Office of Management Certification in the Medicare/Medicaid comments be faxed to the Office of
and Budget (OMB) for each collection of Program for Providers of Outpatient Information and Regulatory Affairs,
information they conduct or sponsor. Physical Therapy and/or Speech- OMB, Attn: FDA Desk Officer, Fax: 202–
The term ‘‘collection of information’’ is Language Pathology; Use: The form is 395–7285, or emailed to oira_
defined in 44 U.S.C. 3502(3) and 5 CFR used as an application to be completed submission@omb.eop.gov. All
1320.3(c) and includes agency requests by providers of outpatient physical comments should be identified with the
or requirements that members of the therapy and/or speech-language OMB control number 0910–0389. Also
public submit reports, keep records, or pathology services requesting include the FDA docket number found
provide information to a third party. participation in the Medicare and in brackets in the heading of this
Section 3506(c)(2)(A) of the PRA Medicaid programs. This form initiates document.
requires federal agencies to publish a the process for obtaining a decision as
to whether the conditions of FOR FURTHER INFORMATION CONTACT:
60-day notice in the Federal Register Domini Bean, Office of Operations,
concerning each proposed collection of participation are met as a provider of
outpatient physical therapy, speech- Food and Drug Administration, Three
information, including each proposed White Flint North, 10A–12M, 11601
extension or reinstatement of an existing language pathology services, or both. It
is used by the State agencies to enter Landsdown St., North Bethesda, MD
collection of information, before 20852, 301–796–5733, PRAStaff@
submitting the collection to OMB for new providers into the Automated
Survey Process Environment (ASPEN). fda.hhs.gov.
approval. To comply with this
requirement, CMS is publishing this Form Number: CMS–1856 (OMB control SUPPLEMENTARY INFORMATION: In
notice. number: 0938–0065); Frequency: compliance with 44 U.S.C. 3507, FDA
Annually, occasionally; Affected Public: has submitted the following proposed
Information Collection Private sector—Business or other for- collection of information to OMB for
1. Type of Information Collection profit and Not-for-profit institutions; review and clearance.
Request: Reinstatement without change Number of Respondents: 350; Total
Guidance for Industry: ‘‘Expedited
of a previously approved collection; Annual Responses: 350; Total Annual
Programs for Serious Conditions—
Title of Information Collection: The Hours: 88. (For policy questions
Drugs and Biologics’’
Medicare Advantage and Prescription regarding this collection contact Peter
Drug Program: Part C Explanation of Ajuonuma at 410–786–3580.) OMB Control Numbers 0910–0389 and
Benefits and Supporting Regulations; Dated: February 2, 2018.
0910–0765—Revision
Use: The Medicare Advantage William N. Parham, III, This information collection supports
disclosure requirements in 42 CFR Director, Paperwork Reduction Staff, Office the previous captioned Agency
422.111(b) sets out the authority for of Strategic Operations and Regulatory guidance. The guidance provides a
CMS to require that Medicare Affairs. single resource for information on
Advantage Organizations (MAOs) [FR Doc. 2018–02433 Filed 2–6–18; 8:45 am] FDA’s policies and procedures related
furnish a written explanation of benefits BILLING CODE 4120–01–P
to the following expedited programs for
(EOB) directly to enrollees, in a manner serious conditions: (1) Fast track
specified by CMS and in a form easily designation, (2) breakthrough therapy
understandable to enrollees, when DEPARTMENT OF HEALTH AND designation, (3) accelerated approval,
benefits are provided under part 422. In HUMAN SERVICES and (4) priority review designation. The
§ 422.216(d)(1), all Medicare Advantage guidance describes threshold criteria
plan types that offer an M+C fee-for- Food and Drug Administration generally applicable to expedited
service plan must provide to plan programs, including what is meant by
enrollees, for each claim filed by the [Docket No. FDA–2013–D–0575] serious condition, unmet medical need,
enrollee or the provider that furnished and available therapy. The guidance
the service, an appropriate explanation Agency Information Collection addresses the applicability of expedited
of benefits. The explanation must Activities; Submission for Office of programs to rare diseases, clarification
include a clear statement of the Management and Budget Review; on available therapy, and additional
enrollee’s liability for deductibles, Comment Request; Guidance for detail on possible flexibility in
sradovich on DSK3GMQ082PROD with NOTICES

coinsurance, copayment, and balance Industry on Expedited Programs for manufacturing and product quality. The
billing. Plans must disclose the Serious Conditions—Drugs and guidance also clarifies the qualifying
information specified in § 422.111(b), as Biologics criteria for breakthrough therapy
specified in § 422.111(a)(3), at the time AGENCY: Food and Drug Administration, designation and provides examples of
of enrollment and at least annually HHS. surrogate endpoints and intermediate
thereafter, 15 days before the annual clinical endpoints used to support
ACTION: Notice.
coordinated election period. Form accelerated approval.

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Federal Register / Vol. 83, No. 26 / Wednesday, February 7, 2018 / Notices 5429

In the Federal Register of November comment on the proposed extension of estimate the burden of the information
8, 2017 (82 FR 51846), we published a this collection of information. No collection as follows:
60-day notice requesting public comments were received. We therefore

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Guidance for industry: Expedited Total Average
Number of responses
programs for serious conditions— annual burden per Total hours
respondents per
Drugs and biologics responses response
respondent

Priority review designation request (0765) .......................... 48 1.7 82 30 2,400
Breakthrough therapy designation request (0765) .............. 87 1.29 113 70 7,910
Fast track designation request (0389) ................................. 140 1.33 187 60 11,220
Fast track premeeting packages (0389) .............................. 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.

The information collection elements information and discussion in a designation and fast track meetings has
regarding priority review designation designation request need not be increased due to increased requests;
and breakthrough therapy designation voluminous, but it should be sufficient however, the hours per request have
requests are reflected in rows 1 and 2 of to permit a reviewer to assess whether remained the same.
table 1 and are currently approved the criteria for fast track designation Dated: February 1, 2018.
under OMB control number 0910–0765. have been met. Leslie Kux,
Meanwhile, fast track designation After the Agency makes a fast track
Associate Commissioner for Policy.
requests and premeeting packages are designation, a sponsor or applicant may
[FR Doc. 2018–02415 Filed 2–6–18; 8:45 am]
currently approved under OMB Control submit a premeeting package that may
include additional information BILLING CODE 4164–01–P
No. 0910–0389. We are therefore
revising OMB control number 0910– supporting a request to participate in
0389 to include all four collection certain fast track programs. The
DEPARTMENT OF HEALTH AND
elements. Information collection burden premeeting package serves as
HUMAN SERVICES
for accelerated approval requests is background information for the meeting
currently approved under OMB control and should support the intended Food and Drug Administration
numbers 0910–0001 (drugs) and 0910– objectives of the meeting. As with the
0338 (biologics). The estimates provided request for fast track designation, the [Docket No. FDA–2014–E–1240]
are based on our experience with the Agency expects that most sponsors or
respective collection elements over the Determination of Regulatory Review
applicants will have gathered such
past 3 years. Period for Purposes of Patent
information to meet existing
A sponsor or applicant who seeks fast Extension; SEDASYS SYSTEM
requirements for preparing an IND,
track designation is required to submit NDA, or BLA. These may include AGENCY: Food and Drug Administration,
a request to the Agency showing that the descriptions of clinical safety and HHS.
drug product: (1) Is intended for a efficacy trials not conducted under an ACTION: Notice.
serious or life-threatening condition, IND (e.g., foreign studies) and
and (2) has the potential to address an information to support a request for SUMMARY: The Food and Drug
unmet medical need. The Agency accelerated approval. If such Administration (FDA or Agency) has
expects that most information to information has already been submitted determined the regulatory review period
support a designation request will have to FDA, the information may be for SEDASYS SYSTEM and is
been gathered under existing summarized in the premeeting package. publishing this notice of that
requirements for preparing an The Agency estimates the total annual determination as required by law. FDA
investigational new drug (IND), new number of respondents submitting has made the determination because of
drug application (NDA), or biologics requests for fast track designation is the submission of an application to the
license application (BLA). If such approximately 140, and the number of Director of the U.S. Patent and
information has already been submitted requests received is approximately 187 Trademark Office (USPTO), Department
to the Agency, the information may be annually. FDA estimates that the of Commerce, for the extension of a
summarized in the fast track designation number of hours needed to prepare a patent which claims that medical
request. A designation request should request for fast track designation is device.
include, where applicable, additional approximately 60 hours per request DATES: Anyone with knowledge that any
information not specified elsewhere by (row 3 in table 1). of the dates as published (in the
statute or regulation. For example, Of the requests for fast track SUPPLEMENTARY INFORMATION section) are
additional information may be needed designation made per year, the Agency incorrect may submit either electronic
to show that a product has the potential granted approximately 132 requests
sradovich on DSK3GMQ082PROD with NOTICES

or written comments and ask for a
to address an unmet medical need from 107 respondents, and for each of redetermination by April 9, 2018.
where an approved therapy exists for these granted requests, a premeeting Furthermore, any interested person may
the serious or life-threatening condition package was submitted to the Agency. petition FDA for a determination
to be treated. Such information may FDA estimates that the preparation regarding whether the applicant for
include clinical data, published reports, hours are approximately 100 hours per extension acted with due diligence
summaries of data and reports, and a list premeeting package (row 4 in table 1). during the regulatory review period by
of references. The amount of The total burden hours for fast track August 6, 2018. See ‘‘Petitions’’ in the

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Document Created: 2018-10-26 13:55:52
Document Modified: 2018-10-26 13:55:52

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by March 9, 2018.
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]
FR Citation		83 FR 5428

83 FR 5428 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 26 (February 7, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration