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, 5428-5429 [2018-02415]
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5428
Federal Register / Vol. 83, No. 26 / Wednesday, February 7, 2018 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
and associated materials (see
ADDRESSES).
CMS–10453 The Medicare Advantage
and Prescription Drug Program: Part C
Explanation of Benefits and
Supporting Regulations
CMS–1856 Request for Certification in
the Medicare/Medicaid Program for
Providers of Outpatient Physical
Therapy and/or Speech-Language
Pathology
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: Reinstatement without change
of a previously approved collection;
Title of Information Collection: The
Medicare Advantage and Prescription
Drug Program: Part C Explanation of
Benefits and Supporting Regulations;
Use: The Medicare Advantage
disclosure requirements in 42 CFR
422.111(b) sets out the authority for
CMS to require that Medicare
Advantage Organizations (MAOs)
furnish a written explanation of benefits
(EOB) directly to enrollees, in a manner
specified by CMS and in a form easily
understandable to enrollees, when
benefits are provided under part 422. In
§ 422.216(d)(1), all Medicare Advantage
plan types that offer an M+C fee-forservice plan must provide to plan
enrollees, for each claim filed by the
enrollee or the provider that furnished
the service, an appropriate explanation
of benefits. The explanation must
include a clear statement of the
enrollee’s liability for deductibles,
coinsurance, copayment, and balance
billing. Plans must disclose the
information specified in § 422.111(b), as
specified in § 422.111(a)(3), at the time
of enrollment and at least annually
thereafter, 15 days before the annual
coordinated election period. Form
VerDate Sep<11>2014
18:17 Feb 06, 2018
Jkt 244001
Number: CMS–10453 (OMB control
number: 0938–1228); Frequency: On
occasion; Affected Public: Private sector
(Business or other for-profits); Number
of Respondents: 468; Number of
Responses: 5,616; Total Annual Hours:
74,880. (For policy questions regarding
this collection contact Natalie Albright
at 410–786–1671.)
2. Type of Information Collection
Request: Reinstatement of a previously
approved collection; Title of
Information Collection: Request for
Certification in the Medicare/Medicaid
Program for Providers of Outpatient
Physical Therapy and/or SpeechLanguage Pathology; Use: The form is
used as an application to be completed
by providers of outpatient physical
therapy and/or speech-language
pathology services requesting
participation in the Medicare and
Medicaid programs. This form initiates
the process for obtaining a decision as
to whether the conditions of
participation are met as a provider of
outpatient physical therapy, speechlanguage pathology services, or both. It
is used by the State agencies to enter
new providers into the Automated
Survey Process Environment (ASPEN).
Form Number: CMS–1856 (OMB control
number: 0938–0065); Frequency:
Annually, occasionally; Affected Public:
Private sector—Business or other forprofit and Not-for-profit institutions;
Number of Respondents: 350; Total
Annual Responses: 350; Total Annual
Hours: 88. (For policy questions
regarding this collection contact Peter
Ajuonuma at 410–786–3580.)
Dated: February 2, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–02433 Filed 2–6–18; 8:45 am]
BILLING CODE 4120–01–P
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:
PO 00000
Notice.
Frm 00029
Fmt 4703
Sfmt 4703
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.
SUMMARY:
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.
E:\FR\FM\07FEN1.SGM
07FEN1
5429
Federal Register / Vol. 83, No. 26 / Wednesday, February 7, 2018 / Notices
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
programs for serious conditions—
Drugs and biologics
Number of
respondents
Number of
responses
per
respondent
Total
annual
responses
Average
burden per
response
Total hours
Priority review designation request (0765) ..........................
Breakthrough therapy designation request (0765) ..............
Fast track designation request (0389) .................................
Fast track premeeting packages (0389) ..............................
48
87
140
107
1.7
1.29
1.33
1.23
82
113
187
132
30
70
60
100
2,400
7,910
11,220
13,200
Total ..............................................................................
........................
........................
........................
........................
34,730
sradovich on DSK3GMQ082PROD with NOTICES
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
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18:17 Feb 06, 2018
Jkt 244001
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
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–E–1240]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; SEDASYS SYSTEM
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined the regulatory review period
for SEDASYS SYSTEM and is
publishing this notice of that
determination as required by law. FDA
has made the determination because of
the submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that medical
device.
DATES: Anyone with knowledge that any
of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by April 9, 2018.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
August 6, 2018. See ‘‘Petitions’’ in the
SUMMARY:
E:\FR\FM\07FEN1.SGM
07FEN1
]]>Agencies
[Federal Register Volume 83, Number 26 (Wednesday, February 7, 2018)]
[Notices]
[Pages 5428-5429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02415]
-----------------------------------------------------------------------
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 [email protected]. 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,
[email protected].
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
